Analytical|Analytical Method Development Validation|CMO|CDMO

Greece

Virtual Booth

Famar offers analytical method development and validation for drug substances, drug products, impurities, related substances & preservatives. Its analytical development services also include validation of microbiological methods and ICH stability studies.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development & Validation

CPhI Worldwide, Milan

Booth #5C27

Aspen API. More than just an API.

Aspen API

Netherlands

Virtual Booth

Aspen API has analytical development laboratories that enable them to rapidly solve analytical challenges and offers a variety of analytical method development & subsequent validation, method transfer, ICH stability studies, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

CPhI Korea

Attending

Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

Bachem AG

Switzerland

Virtual Booth

Bachem has extensive analytical expertise and offers all analytical services to ensure successful product development. Its GMP-compliant analytical capabilities include method development and validation, stability studies, nitrosamine determination, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

BIO Asia-Taiwan

Attending

With Fermion, start the journey of your innovative API.

Fermion Oy

Finland

Virtual Booth

Fermion offers the development of analytical methods for SMs, IMs & APIs for Phase I, II & III together with the validation of API analytical methods.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

CPhI Korea

Attending

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Seqens

France

Virtual Booth

Seqens offers standalone analytical services including method development and validation, and method qualification. It has a proven track record of full development and validation studies, optimization of existing methods & transfer of validated methods.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development and Validation

ChemOutsourcing

Attending

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Cayman Chemical Company Inc

U.S.A

Virtual Booth

Our contract services group helps companies turn their new drug ideas into reality. Whether for phase I, phase II, phase III, or toxicology studies, we specialize in developing new synthetic routes while providing all necessary support to ensure regulatory compliance.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

BIO Asia-Taiwan

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Mission | CDMO

Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

U.S.A

Virtual Booth

Mission CDMO provides a full spectrum of analytical services from method development to finished product release & stability testing. It also offers method transfer, cleaning validation, in-process, and release testing, USP/NF testing, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

BIO Asia-Taiwan

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PMC Isochem

PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

France

Virtual Booth

From method development to transfer and validation, PMC Isochem is well-equipped to address analytical needs for APIs, intermediates, and excipients with precision and efficiency. It also provides R&D support for cleaning analytical method development.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

CPhI Worldwide, Milan

Booth #3F41

Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

Renejix

Renejix is a contract development and manufacturing organization that offers analytical method development and validation services. It also has experience in method transfer, optimization, qualification, and chiral HPLC & SFC method development.

U.S.A

Virtual Booth

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

BIO Asia-Taiwan

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Sharp

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

U.S.A

Virtual Booth

Sharp offers clinical trial services and develops analytical methods used throughout various phases of their clients’ drug development and manufacturing projects.

CLINICAL ANALYTICAL & RESEARCH SERVICES

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Contract Pharma 2024

Booth #68

Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

Skyepharma

France

Virtual Booth

Skyepharma offers various analytical services such as method development, validation and transfer, and process optimization. It also develops analytical methods in a limited time, from bibliography studies to screening parameters.

ANALYTICAL DEVELOPMENT SERVICES

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

DDF Summit, US

Attending

Zach System is committed to providing Highly Customized Solutions for all your Development Programs.

ZACH System SA

France

Virtual Booth

Zach System offers analytical development (UV/CAD/RID-HPLC, GC, HS-GC), structural characterization (GC-MS, HPLC- MS, NMR, IR), etc.

ANALYTICAL DEVELOPMENT

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

ChemOutsourcing

Exhibiting

M2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.

M2i Group

France

Virtual Booth

M2i offers development and validation of analytical methods, complete development of synthetic route and implementation, scale-up, process industrialization, technical batch production, and multi-ton GMP production.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

M2i Group Analytical Method Development & Validation

CPhI Worldwide, Milan

Booth #4B109

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

Mikart

U.S.A

Virtual Booth

Mikarts' R&D lab offers a full range of analytical method development and validation services for pharmaceutical formulations. It also involves analytical method transfer, verification of USP methods, test method development and optimization, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Contract Pharma 2024

Attending

Neuland Laboratories- A dedicated 100% API provider.

Neuland Laboratories

India

Virtual Booth

Neuland has considerable expertise in analytical method development for complex molecules and genotoxic impurities. It also provides method validation, method transfer, and method optimization solutions for drug development to its clients.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Peptide Therapeutics

Exhibiting

Quotient Sciences- Molecule to Cure. Fast.

Quotient Sciences

United Kingdom

Virtual Booth

Quotient Sciences provides the best analytical support, delivering phase-appropriate method development and validation, candidate screening and drug product analysis.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Quotient Sciences Analytical Method Development & Validation

ChemOutsourcing

Attending

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Fresenius SE & Co. KGaA

Germany

Virtual Booth

We provide full QC support - physical, chemical, and microbiological - for starting materials, finished products, and in-process control. In-house expertise is available to develop and validate new analytical methods and to import and modify existing methods.

DEVELOP & VALIDATE NEW ANALYTICAL METHODS

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Menadiona

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Spain

Virtual Booth

Menadiona offers process development and validation of analytical methods, feasibility evaluations, pilot plant batches, validation batches, regulatory support and commercial production for APIs and advanced intermediates.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Solara Active Pharma Sciences

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India

Virtual Booth

Solara, Contract Research and Manufacturing Services (CRAMS) provider has a range of experience from 5 to 30 years in analytical services. They provide extensive analytical method development, qualification and validation capabilities.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Societal CDMO

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U.S.A

Virtual Booth

Recro provides diverse analytical services such as method development and validation (assay, impurities, dissolution and cleaning) and other testing services to assess compound quality.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Angelini Pharma

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Italy

Virtual Booth

Angelini has custom development and manufacturing capabilities including analytical development and validation, manufacturing pilot, pre-validation, validation and commercial batches, ICH stability studies, safety and toxicology assessments, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Bioplus Life Sciences

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India

Virtual Booth

BioPlus Life Sciences has analytical expertise in method development and validation, scalability study, multimedia dissolution profiles, elemental impurity study, active sourcing and residual solvents testing.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

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Anacipher

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India

Virtual Booth

We undertake method validation studies as per ICH guidelines. This includes analytical method validation of compendial and non compendial chromatographic method. We also undertake project for analytical method development and validation for cleaning procedures.

ANALYTICAL METHOD VALIDATION STUDIES

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Madras Pharmaceuticals

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Madras Pharma's analytical development capabilities include development & validation of various analytical testing procedures, content uniformity, dissolution, related substances, residual solvents, other in-house test procedures, etc.

India

Virtual Booth

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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KriSan Biotech

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Taiwan

Virtual Booth

KriSan Biotech has extensive experience in analytical method development and validation, analytical research on raw materials, intermediates and active pharmaceutical ingredients (APIs).

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

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Vitas Analytical Services

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Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

Norway

Virtual Booth

Digital Content

METHOD DEVELOPMENT, OPTIMIZATION & VALIDATION

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Acceleration Laboratory Services

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Acceleration Laboratory Services is the foremost contract solutions provider for pharmaceutical research. Their ultimate goal is to deliver superior solutions to clients, on time, and on point, while maintaining a fun and empowering work environment.

U.S.A

Virtual Booth

Digital Content

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Sai Life Sciences Limited

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India

Virtual Booth

Sai Life Sciences offers analytical method development & validations for NCEs. Structure identification & confirmation of impurities is integral part of the analytical method development.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Curia

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U.S.A

Virtual Booth

Curia's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer covering procedures for APIs, formulations, cosmetics, raw materials, etc.

METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

Category: Analytical Method Development

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Quantex Laboratories

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Quantex Laboratories provides cost effective outsourced cGMP and GLP laboratory services to industry. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care producuts, and raw materials.

U.S.A

Virtual Booth

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METHOD DEVELOPMENT & VALIDATION

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Boston Analytical

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Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

U.S.A

Virtual Booth

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METHOD DEVELOPMENT & VALIDATION

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Pharma Service: Analytical

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mKnal Global Solutions

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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

India

Virtual Booth

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Admix Pharma Laboratories, LLC

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With Admix Pharma Laboratories, LLC you will enjoy a host of attractive benefits that can effectively extend your in-house pharmaceutical products development and manufacturing capabilities for long and short term projects.

U.S.A

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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JGL d.d

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Croatia

Virtual Booth

JGL’s laboratories are equipped for development and validation of analytical methods, preformulation testing, formulation development and technological process optimization.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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GALIEN LPS

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Galien LPS offers analytical services which covers: Stability studies ICH and On-going; Analyses of raw materials and finished products; Optimization and modernization of methods , HPLC to UPLC transposition ; Validation; Reports, trend analysis.

France

Virtual Booth

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OPTIMIZATION, MODERNIZATION & VALIDATION OF METHODS

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UQUIFA

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Spain

Virtual Booth

Uquifa has capabilities for analytical method validation, stability studies, process validation, working standard supply, scale up to commercial, process transfer, etc.

ANALYTICAL METHOD VALIDATION

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Merck Millipore

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U.S.A

Virtual Booth

Accelerate and simplify your path to market by letting our BioReliance® Validation Services help you select, test and validate the filters, assemblies and single-use systems for drug manufacturing processing.

BIORELIANCE® VALIDATION SERVICES

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Nutrasource

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Our product analytics division offers full analytical testing services to ensure your products and ingredients comply with regulatory requirements for quality and purity.

Canada

Virtual Booth

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FORMULATION VALIDATION SUPPORT TESTING

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Proveris Scientific

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U.S.A

Virtual Booth

Proveris offers services from formulation and device screening, method development, through-life product testing, to regulatory submission, quality release, and out of specification (OOS) investigations for orally inhaled and nasal drug products (OINDPs).

METHOD DEVELOPMENT FOR NASAL DRUG PRODUCTS

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Bio-Technology General Israel Ltd.

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Our 1,700 square meter development laboratories and pilot plants are active in: Protein purification.

Israel

Virtual Booth

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BIOPHARMACEUTICAL ANALYTICAL DEVELOPMENT

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Tepnel Pharma Services

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Tepnel performs analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.

United Kingdom

Virtual Booth

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ICH Q2 (R1) & cGMP COMPLIANT METHOD DEVELOPMENT & VALID...

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PSR Pharma Science and Research

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PSR has necessary expertise & access to advanced technologies to develop the formulation and also, through the use of targeted analytics, supply the client with the relevant information needed to aid in the correct selection of formulation/drug delivery system to meet the clients requirements.

New Zealand

Virtual Booth

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ANALYTICAL METHOD DEVELOPMENT & VALIDATIONS

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Crenza Pharma

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Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

India

Virtual Booth

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CCIT METHOD DEVELOPMENT & VALIDATION

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FumoPrep

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FumoPrep is an analytical CRO that develops and validates analytical methods for single and multicomponent (even UVCB) test items in a wide range of concentrations and matrices. The studies are conducted in accordance with the relevant GLP regulations.

Hungary

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Sushen Medicamentos Pvt. Ltd

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SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

India

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Prague Scientific

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Czech Republic

Virtual Booth

Prague Scientific offers analytical method development, validation and transfer, specification setting, stability and stress testing, CMC and dossier preparation.

ANALYTICAL DEVELOPMENT

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Ash Stevens, Inc.

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U.S.A

Virtual Booth

Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

METHODS DEVELOPMENT & METHODS VALIDATION

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QUINTA-ANALYTICA s.r.o

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Czech Republic

Virtual Booth

Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

METHOD TRANSFER & VALIDATION

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BirgiMefar Group

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Stability studies & Analytical Method Validations & Process Validation Scale-up batch production.

Turkey

Virtual Booth

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ANALYTICAL METHOD VALIDATIONS

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Oncomed Manufacturing A.S

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Czech Republic

Virtual Booth

Oncomed offers end-to-end solutions covering the whole lifecycle of products with a focus on contract services including analytical method development & validation, development, material and final product release, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Santa S.A

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We offer full service solutions and project management for cost effective product development in pharmaceutical as well as food /nutraceutical areas.

Romania

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ANALYTICAL DEVELOPMENT, VALIDATION & TRANSFER

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Pharma Service: Analytical

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CLEARSYNTH LABS LIMITED

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CLEARSYNTH team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

India

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Quantex Laboratories

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Our laboratory has 25 years of in depth experience with designing and executing method development and validation, verification and method transfer protocols and experiments.

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ACTA Laboratories Inc

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ACTA performs cGMP method validation in accordance with USP and ICH requirements. Parameters normally validated are accuracy, precision, specificity, limit of detection, limit of quantitation, linearity, range and robustness. ACTA’s staff is highly experienced with method development for

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cGMP METHOD VALIDATION & DEVELOPMENT

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Mithra CDMO

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By Complying major guidelines and pharmacopeias (ICH, EMA, FDA, USP, EP), Our mission is to develop and validate reliable methods analytical methods for drug substances, excipients, drug products, raw materials and cleaning methods and diffusion profiles adapted to formulation.

DEVELOPMENT & VALIDATION OF DIFFUSION PROFILES

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ORIT LABS LLC

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Orit Laboratories comprises of analytical testing laboratories and formulation development areas operating under cGLP and cGMP. Orit has a number of products already approved and marketed, with several additional products already filed and under FDA review.

ANALYTICAL CAPABILITIES- METHODS VALIDATION & TRANSFER

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ChemCon GmbH

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Germany

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ChemCon has developed and validated analytical methods in-house since 2001. It offers transfer of existing methods & establishment of new methods as per the international monographs, risk assessment of new methods, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Saneca Pharmaceuticals

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Our finished dosage form development team has successfully created numerous control release and extended release formulations, successfully ensuring afterward rapid scale up to full production.

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Etico Lifesciences

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India

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Our cross functional teams at Etico namely are Business Development, Formulation Development, Analytical Development, Development Quality Assurance, Microbiology, Project Management, Regulatory Affairs, IPR management, HR, Finance & IT.

METHOD DEVELOPMENT, VALIDATION & TRANSFERS

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Arevipharma

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The quality of API manufactured by Arevipharma has sealed their good reputation among customers. Raw materials, intermediates, API and primary packaging are checked in accordance to specification and communicated and professionally documentated in an efficient manner.

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DEVELOPS, VALIDATES & TRANSFERS NEW METHODS OF ANALYSIS

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Unither Pharmaceuticals

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France

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Unither analytical services include method development & validation, analytical method transfer & ICH stability studies. They provide extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Neopharm Labs Inc

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All analyses are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia. Our experienced microbiology team can perform a wide range of compendial assays, including: USP/NF, AAMI, BP/Ph. Eur, AOAC, AWWA, FDA-BAM and Client supplied methods.

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Dishman Carbogen Amcis

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India

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Dishman's analytical services support both process control and material characterization including method development & validation for laboratory and production chemistry from initial raw material release to release of the final APIs.

METHOD DEVELOPMENT & VALIDATION

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Flagship Biotech International Pvt. Ltd

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India

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Flagship biotech had established A state-of-art Research and Development Centre (R&D) at Mumbai - focused towards developing new products, improving existing products as well as drug delivery systems and expanding product applications.

ANALYTICAL DEVELOPMENT

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Arbro Pharmaceuticals Pvt. Ltd

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Our laboratory has carried out hundreds of method validation studies for leading pharmaceutical companies in India and around the world helping them successfully register their products in various countries.

India

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METHOD VALIDATION

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Maithili Life Sciences

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Development of reliable analytical methods for in-process control for intermediates and APIs.

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DEVELOPMENT OF RELIABLE ANALYTICAL METHODS

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Progenerics Pharma Pvt Ltd

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We provide full range of analytical services, State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

India

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METHOD DEVELOPMENT & VALIDATION

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SEQUENT SCIENTIFIC LTD

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India

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To keep abreast of the industry requirement, we invest in the latest instruments and our laboratory has enough space to undertake client specific requirements for continuous routine or bulk analysis.

METHOD DEVELOPMENT, VALIDATION & TRANSFER

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RD Laboratories

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R.D. Laboratories has extensive experience providing both method development and validation services. Most often we are asked to develop a method for the analysis of an active drug substance in a finished product.

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DEVELOPING A METHOD FOR THE ANALYSIS OF AN API IN FDF

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ScinoPharm Taiwan, Ltd

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Taiwan

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ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

ANALYTIC METHODS DEVELOPMENT & VALIDATION

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Ascent Innovative Medicines

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India

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With our vast experience we add exponential value to our client’s R&D programs at every stage of the drug development. We serve as a vital link between the pharmaceutical companies and the healthcare industry.

ANALYTICAL METHOD DEVELOPMENT

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Adare Pharma Solutions

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Adare Pharma Solutions is a CDMO that provides development capabilities for analytical method development & validation, IMPD manufacturing & QP release, tech transfer, ICH stability programs at all conditions, etc.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Zenvision Pharma LLP

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India

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Zenvision has standalone analytical services including complete analytical support for dossier filing.

METHOD DEVELOPMENT, QUALIFICATION, VALIDATION, TRANSFER

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Anacipher

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India

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We have extensive experience in chromatographic method development and validation including reverse phase, normal phase and Chiral HPLC methods and Head space GC methods. We have expertise in spectroscopic, titrimetric and particle size analysis methods development and method validations.

CHROMATOGRAPHIC METHOD DEVELOPMENT & VALIDATION

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Curida AS

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Norway

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Curida has an extensive knowledge and expertise in developing? and validating methods for finished products including cleaning validation

METHOD DEVELOPMENT & VALIDATION

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GRAM Laboratory Inc

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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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FILTER QUALIFICATION & VALIDATION STUDIES

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Ropack Inc

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Our cGMP lab performs method development and validation for a broad spectrum of pharmaceutical compounds and dosage forms during various drug development stages,

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METHOD DEVELOPMENT & VALIDATION

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PharmaVize NV

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Pharmavize operates an audited 1,600-m2 GMP facility serving clients from all over the world. We are thoroughly familiar with the European and American regulatory frameworks and guarantee compliance with all applicable guidelines and directives.

Belgium

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METHOD VALIDATION & TRANSFER ACTIVITIES

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Shijiazhuang Rainbowlabs Pharmaceutical Technology

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Rainbowlabs has received the highest accreditation from the U.S. FDA, Health Canada, ISO and CNAS over the past number of years. Rainbowlabs can do analytical method development based on customers requirement.

China

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VERIFICATION OF HPLC ANALYTICAL METHODS

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Shijiazhuang Rainbowlabs Pharmaceutical Technology

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Rainbowlabs has received the highest accreditation from the U.S. FDA, Health Canada, ISO and CNAS over the past number of years. Rainbowlabs can do analytical method development based on customers requirement.

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VERIFICATION OF GC ANALYTICAL METHODS

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Recipharm AB

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Sweden

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Recipharm analytical solutions support customers with stand-alone analytical requirements which includes analytical method development & validation, stability program design & analysis, pharmacopeial testing & verification and extractables & leachables.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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STABICON LIFE SCIENCE PVT LTD

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To ensure successful method development there is a requirement for highly skilled analytical judgement. The 'purpose' of the method needs to be determined with some clarity and thoroughness as this will ultimately determine the long-term success of the new method.

India

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Catalent Pharma Solutions

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U.S.A

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Catalent offers various analytical services including Method Development / Validation / Transfer, Compendial Testing, Microbiology Testing, Structure Characterization, Release & Stability Testing, Specialized Testing, etc.

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Aizant Drug Research Solutions Pvt. Ltd.

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India

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Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

METHOD DEVELOPMENT, VALIDATION & TRANSFER

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Solvias

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Switzerland

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Solvias has experience in developing analytical methods throughout the entire drug lifecycle. It helps in selecting promising analytical methods and carry out development, validation and transfer within the constraints of GMP and registration deadlines.

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Osmopharm

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Osmopharm provides analytical services such as analytical and production validations along with other services like stability studies, technical dossier (CTD Format), bulk manufacturing, capsules filling-tabletting, blistering and bottle filling, etc.

Switzerland

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ANALYTICAL SERVICES

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Doctor's Analytical Laboratories

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DALPL provides analytical method development and validation services at the pharma division for genotoxic impurity [nitrosamine impurities] quantification studies, carryover impurity studies, elemental impurities, extractable & leachables, etc.

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Symbiosis Pharmaceutical Services

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United Kingdom

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Symbiosis Pharma has capabilities to offer analytical method development and validation, analytical method transfer, filter compatibility testing and container closure compatibility testing.

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DPT Laboratories, Ltd

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Analytical method development, assessment and validation for small molecules, peptides and proteins.

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Provepharm Life Solutions

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France

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Provepharm offers small molecules design and synthesis with expertise in analytical method development and analytical method validation.

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Megsan Labs Private Limited

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

India

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METHOD DEVELOPMENT & VALIDATIONS

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Softigel Procaps

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Colombia

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Softigel's pre-clinical & phases I & II services include pre-formulation, formulation development, analytical method development & evaluation, cleaning residure test, CTM lots testing, analytical method development & validation, etc.

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Tapemark Company

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U.S.A

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Tapemark's cGMP compliant in-house analytical lab provides full analytical support such as method development, transfer, verification, & validation, final product release testing, ICH stability storage and testing, compendial raw material testing, etc.

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Bellen Chemistry

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Bellen Chemistry, with experienced teams, state-of-the-art equipment, tools and techniques has over a decade of experiences and successful track records in developing compliant and clinical phase-appropriate analytical methods and validations.

China

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ANALYTICAL METHODS & VALIDATIONS

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Curtis Health Caps

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Curtis Health Caps offers various pharmaceutical services such as development & validation of analytical methods, optimization & transfer of analytical methods in accordance with the ICH guidelines, pharmacopoeial & GMP requirements.

Poland

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Arcinova

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United Kingdom

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We produce validated analytical methods to reassure clients that data is reliable before moving on to regulatory stages for first-in-human tests. We provide the highest quality method development & validation to support our clients.

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Eurofins BioPharma Services

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France

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Eurofins BioPharma Product Testing network of laboratories can support the development and validation of virtually any test for your starting material, API, bulk product, finished product, intermediate or packaging under cGMP guidelines.

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Evotec

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Germany

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Evotec scientists are aided by the latest generation software tools, such as DryLab®, Empower™ and Method Validation Manager (MVM) to support both development and validation and to deliver effective solutions for each pharmaceutical development phase

METHOD DEVELOPMENT AND VALIDATION

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Zelmic

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Zelmic's in-house GMP laboratory offers analytical method development services to support the early phase of pharmaceutical formulations. It also provides analytical method verification and validation through GMP batch release testing.

Sweden

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Ortiv-Q3 Research

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India

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Ortiv-Q3 Research is equipped with a wide range of state-of-the-art instrumentation capabilities for developing & validating analytical methods. It also provides analytical method automation, physiochemical Q3 characterization, and IVRT services.

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Bluepharma

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Portugal

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The experienced R & D team is also responsible for the development and validation of efficient and sensitive analytical methods.

DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS

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Chromcore Lifesciences

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Chromcore offers various analytical services such as analytical method development & validation, analytical method transfer, analytical method verification, etc.

India

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METHOD DEVELOPMENT & VALIDATION SERVICES

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Labiana Life Sciences S.A

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Spain

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In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries and provides development and validation of analytical methods.

DEVELOPMENT & VALIDATION OF ANALYTICAL METHOD

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ARx

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ARx supports global partnerships with various project capabilities including analytical method development & validation, analytical testing for method development, transfer, verification, validation, and final product release.

U.S.A

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Lonza Capsugel

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U.S.A

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Capsugel® capsules are highly customizable solutions based on precision product design and deep technology expertise that offer pharmaceutical customers increased speed to market and commercial success rate, even with challenging compounds.

PRODUCT DEVELOPMENT AND CUSTOMIZATION

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Pharma Service: Analytical

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Almelo

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India

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The Almelo Research Center (ARC) is a fully established facility for our in-house and custom product R&D services.

DEVELOPMENT OF ANALYTICAL METHODS

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Cambrex Corporation

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U.S.A

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Cambrex focuses on efficiently developing robust and high- quality analytical methods that deliver reliable results. We have a vast range of capabilities in instrumentation and detectors including high-throughput column screening.

ANALYTICAL DEVELOPMENT & VALIDATION

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SGS Life Sciences

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U.S.A

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We are able to serve pharmaceutical and biopharmaceutical companies of all sizes with a range of tests for drug development at both pre- clinical and clinical stages from early to late phase.

METHOD DEVELOPMENT, OPTIMIZATION & VALIDATION

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AlbyPharma

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Raw material, intermediate testing, finished product testing, stability testing and validation testing laboratory.

Ireland

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VALIDATION TESTING LABORATORY

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Pharma Service: Analytical

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Onyx Scientific

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United Kingdom

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Onyx Scientific has a highly experienced team of analytical specialists to ensure all the analytical needs of their projects are met. All of Onyx’s methods are developed with cGMP quality & will be suitable for validation at the appropriate phase.

ANALYTICAL DEVELOPMENT

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Appcure Labs

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Appcure Labs delivers high-quality analytical development services including analytical methods development and validation, method transfer, cleaning methods development and validation, and stability studies as per ICH guidelines.

India

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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JSL Health Sciences

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JSL Health Sciences is a contract research and development organization that offers analytical services including analytical method development and method validation.

India

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Healios Labs

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Healios provides analytical method development and validation services with its cGMP-certified laboratory and supports your cGMP testing needs at any stage of development.

U.S.A

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Lamda Laboratories

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Lamda’s analytical options are available on a stand-alone bases or as part of a full development package such as Analytical method development & Validation, Forced degradation studies, Photostability studies, Method transfer, API controls etc

Greece

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METHOD DEVELOPMENT & VALIDATION

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Cyndea Pharma S.L

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Spain

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Cyndea Pharma focuses its efforts on the development and manufacturing of generic drugs with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with high activity products.

ANALYTICAL DEVELOPMENT

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Olive Healthcare

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Olive healthcare is a fully integrated developer, manufacturer and marketer of broad range of soft gelatin formulations with a strong regulatory and infrastructure back end to support its r&d and growth strategy in global markets.

India

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ANALYTICAL METHOD DEVELOPMENT & EVALUATION

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Servier

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France

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Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

ANALYTICAL DEVELOPMENT & VALIDATION

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PYRAMID Laboratories, Inc

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PYRAMID is highly specialized in the area of HPLC and GC method development. PYRAMID has an established reputation for developing methods for difficult and unusual compounds in complex products and matrices. All Validations are cGMP/ICH compliant.

U.S.A

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METHOD DEVELOPMENT, VALIDATION AND SUPPORT TESTING

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Rafarm S.A

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Greece

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Our researchers executes every phase of the development process with the utmost care, including identification of reliable suppliers of active ingredients, realization of laboratory and industrial-scale trial batches, development and validation of analytical methods and stability studies.

DEVELOPMENT & VALIDATION OF ANALYTICAL METHODS

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Novick Biosciences

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Novick Biosciences is a CDMO which offers various services including Analytical method development & validation, Pre-formulation Development, Formulation development & Optimization, Scale Up & Technology transfer.

India

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ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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Avivia

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We develop all methods that are needed in the different phases to support the chemical and pharmaceutical development, and when the time is there we transfer these methods to a qualified lab for the final quality testing.

Netherlands

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METHOD DEVELOPMENT AND VALIDATION

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Basic Pharma

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Basic Pharma Laboratory performs tests according to Ph. Eur. or USP methods; if no standard method is available, we are also able to design and validate in-house methods according to customer requirements.

Netherlands

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DESIGN & VALIDATE IN-HOUSE METHODS

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Legacy Pharmaceuticals Switzerland

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Switzerland

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Legacy Pharmaceutical supports you with process development, process validation & validation of analytical methods, commercial production, & sales of your products. Perfect planning and sustainable documentation result in successful product transfer.

PROCESS VALIDATION & VALIDATION OF ANALYTICAL METHODS

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Stason Pharmaceuticals, Inc.

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U.S.A

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Analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. We also have a DEA analytical permit for CII-CIV products.

METHOD DEVELOPMENT & VALIDATION

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Avaca Pharma

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AvacaPharma's scientific team has an up to date understanding of product development aspects. Analytical scientists focuses on method development, validation, instrumentation, technology transfer and stability studies.

India

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ANALYTICAL DEVELOPMENT & VALIDATION

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Diverchim S.A.

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France

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In accordance with the ICH Q7 and the cGMP guidelines, DIVERCHIM validates the analytical methods developed by its teams to ensure registration and marketing authorizations by Health Agencies.

ANALYTICAL VALIDATION

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Biolink LifeSciences

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U.S.A

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Biolink Life Sciences offers a full range of services including analytical method development & validation, custom synthesis, process development, stability studies, reference standard synthesis, pre-formulation & formulation development services.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

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M2M Pharmaceuticals Ltd

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M2M Pharmaceuticals Ltd, a Contract Research Organization (CRO) supports early stage product development for pharmaceutical, food and biotech companies with various services in Method Development and Validation, Physico-Chemical Analysis, Formulation and Quality/Regulatory support.

United Kingdom

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METHOD DEVELOPMENT AND VALIDATION

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GALENIX INNOVATIONS

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With more than 15 years of know how, experience, and a very large state-of-the art analytical platform, Galenix performs analytical development and validation works in very short timeframes.

France

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ANALYTICAL DEVELOPMENT AND VALIDATION

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Pace Analytical Services, LLC

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U.S.A

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Pace Analytical Life Sciences offers microbiology laboratory services for the qualitative and quantitative assessment of products, packaging and the manufacturing environment.

METHOD DEVELOPMENT & VALIDATION

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Lubrizol Life Science Health

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U.S.A

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The work in Analytic Services ranges from early method development through and onto validation and clinical and commercial support. With decades of experience, our staff will help you design and successfully execute a phase-appropriate analytical strategy

METHOD DEVELOPMENT AND VALIDATION

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Megsan Labs Private Limited

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Analytical method development and validation services are performed as per ICH Qz, |JSP , method verifications as per <1226>, and/or customer requirements.

India

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METHOD DEVELOPMENT & VALIDATION

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Avaca Pharma

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AvacaPharma's scientific team has an up to date understanding of product development aspects. Analytical scientists focuses on method development, validation, instrumentation, technology transfer and stability studies.

India

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METHOD DEVELOPMENT, VALIDATION & TRANSFER

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Globela Pharma

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Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

India

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METHOD DEVELOPMENT & VALIDATION

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Siegfried AG

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Switzerland

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Our analytical departments support the whole product lifecycle of drug substances and drug products with scientific competence and an extensive instrument pool. Validation, verification and Transfer of analytical methods.

500 METHOD VALIDATIONS IN ACCORDANCE WITH ICH GUIDELINE...

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Aragen Life Sciences

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India

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GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

METHOD DEVELOPMENT, VALIDATE & TRANSFER

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Ardena

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Belgium

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Ardena’s state-of-the-art, GMP qualified, equipment and facilities offer analytical method development services to support the development of drug substances and complex bulk drug products like nano-formulations.

ANALYTICAL METHOD DEVELOPMENT

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Aragen Life Sciences

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India

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GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

METHOD DEV., QUALIFICATION, VALIDATION & TRANSFER

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Cebiphar

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France

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