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Analytical Method Development and Validation Before the analysis of leachables samples, a test method must be developed and validated to ensure that the analytes of interest are not obscured or affected by the formulation of the drug product. Appropriate analytes of interest for testing are to be dertermined. Drawing from resources available in literature, or performing extractables profiles in chemistry laboratory, specific analytes of interest for a drug product are determined. Methods are developed for these analytes in the presence of drug product, ensuring that any samples preparation procedures are incorporated into these methods. Following development, the method is then validated per ICH guidelines. Various studies involved in validation services include: linearity testing, precision (repeatability and intermediate precision testing), accuracy, specificity, limit of detection, limit of quantification, range, robustness and stability of test solutions. Different techniques with a multitude of drug product solutions are Gas chromatography (GC), Gas chromatography/mass spectroscopy (GC/MS), High-performance liquid chromatography (HPLC), High-performance liquid chromatography/mass spectroscopy (HPLC/MS), Inductively coupled plasma (ICP) spectroscopy, Ultraviolet/visible (UV/VIS) spectroscopy etc. New Sterilization Process Development and Characterization Solutions for FDA’s requirements for the testing required for a 510(k) submission for a new sterilization process can be provided by the laboratories. Biological and chemical indicators development, perform testing to prove that the sterilizer and sterilized materials are safe, and investigate the toxicity of any residuals. Laboratories GMP labs perform method development and validation for a broad spectrum of biopharmaceuticals and dosage forms across all phases of pharmaceutical development. Apart from method development, experimental design, method validation protocol development, gap analyses, remedial method validation and customized method validation reports may also be provided. Method development and validation for chromatography techniques including HPLC, UPLC, GC, SEC and IC with a variety of detection technologies including UV, DAD, FL, MS, ELSD, RI, PAD, FID, TCD, MALS, CAD Method development and validation for stability-indicating assays and related substances methods for drug substance and drug products, such as, tablets, capsules, suspensions, creams, injectables, nasal sprays, pMDIs, DPIs, medicated feeds, drug-eluting stents Method development, validation and quality control services for: Dissolution (IR, ER, MR), Organic volatile impurities, Preservatives and antioxidants, Clinical comparator assay and dissolution. Analytical support for process and cleaning validation on various surfaces by HPLC, UPLC, TOC and GC, Dose verification for GLP studies, Bioequivalency, in vitro pharmaceutical equivalency testing. Quality control support for Dosing solution analysis for toxicology studies, Customer product complaint testing, Field monitoring testing, Generation of statistical quality control charts.

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ACTA Laboratories Inc

AMRI

AbbVie Contract Manufacturing

Acceleration Laboratory Services

Admix Pharma Laboratories, LLC

Aizant Drug Research Solutions Pvt. Ltd.

AlbyPharma

Almelo Private Limited

Anacipher

Arbro Pharmaceuticals Pvt. Ltd

Arevipharma GmbH

Ascent Innovative Medicines

Ash Stevens, Inc.

AvacaPharma

BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

Basic Pharma

Bio-Technology General Israel Ltd.

BirgiMefar Group

Boston Analytical

CLEARSYNTH LABS LIMITED

CU Chemie Uetikon GmbH

Cambrex Corporation

Cayman Chemical Company Inc.

Cebiphar

ChemCon GmbH

Crenza Pharma

Curida AS

Cyndea Pharma S.L

DPT Laboratories, Ltd

Dishman Carbogen Amcis

Diverchim S.A.

Etico Lifesciences

Famar S.A.

Farmak A.S

Farmhispania, S.A.

Fermion Oy

Flagship Biotech International Pvt. Ltd

Fresenius SE & Co. KGaA

GALENIX INNOVATIONS

GALIEN LPS

GRAM Laboratory Inc

GVK Biosciences

Gentec Pharmaceutical Group

GfM mbH Gesellschaft fur Micronisierung mbH

Globela Pharma Pvt. Ltd.

KriSan Biotech

Labiana Life Sciences S.A

Legacy Pharmaceuticals Switzerland

M2I Life sciences

M2M Pharmaceuticals Ltd

Maithili Life Sciences Private Limited

Malladi Drugs & Pharmaceuticals Limited

Megsan Labs Private Limited

Menadiona, S.L.

Merck Millipore

Mithra CDMO

Neopharm Labs Inc

Neuland Laboratories Inc

Novick Biosciences

Nutrasource

ORIT LABS LLC

Olive Healthcare

One Pharma S.A

PCI Synthesis

PHARMATHEN INDUSTRIAL SA

PSR Pharma Science and Research

PYRAMID Laboratories, Inc

Pace Analytical Services, LLC

Particle Sciences

Pfanstiehl, Inc

Pfizer CentreOne

PharmaVize NV

Progenerics Pharma Pvt Ltd

QUINTA-ANALYTICA s.r.o

Quantex Laboratories

RD Laboratories

RECRO GAINESVILLE

Rafarm S.A

Ropack Inc

SEQUENT SCIENTIFIC LTD

STABICON LIFE SCIENCE PVT LTD

Saneca Pharmaceuticals

Santa S.A

ScinoPharm Taiwan, Ltd

Servier CDMO

Shijiazhuang Rainbowlabs Pharmaceutical Technology Co.Ltd

Siegfried AG

Skyepharma

Softigel Procaps

Stason Pharmaceuticals, Inc.

Sushen Medicamentos Pvt. Ltd

Tepnel Pharma Services

UQUIFA

Unither Pharmaceuticals

Vitas Analytical Services

ZACH SYSTEM SPA

ZCL CHEMICALS LTD

Zenvision Pharma LLP

mKnal Global Solutions

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Virtual BoothQuinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Method Transfer & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothExpert and Agile CDMO Partner for tailor-made solutions.

Analytical Development & Expertise

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Skyepharma's analytical experienced team supports the pharmaceutical development during every phase of the development process. Analytical validation, characterization capabilities, stability analysis, ICH Q3D and E/L capabilities.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothPfizer CentreOne™ is a global CDMO embedded within Pfizer.

Method Development and Validation

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We perform analytical development activities involving method development, impurities & degradation identification, compendial method verification, fate and purge studies etc.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothDevelopment, production, marketing of APIs, Intermediates & specialities// FDA inspected.

Analytical Methods & Equipment Validation

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Our analytical centre provides these methods & equipment: Analytical methods and equipment are validated; LCMS, GCMS, HPLC, TLC; UV/VIS and IR spectrometry; Capillary electrophoresis; Thermal analysis – DSC, Calorimetry; NMR (400 MHz) + xRAY; PSD analysis

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Pharma Service: Analytical

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Virtual Booth100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

Analytical Method Development & Validation

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State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

Method Development & Validation

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AMRI's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothGlobal leader for science based integrated drug development solutions

Analytical Method Development

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothUSFDA, EDQM, ANSM, KFDA, TGA Inspected// in 60 countries // Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl

Analytical Method Development & Validation

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Malladi’s Research & Development is well-equipped with a wide range of process & analytical capabilities such as method development & specification development for raw material/API, method validation, impurity identification and stability studies.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothPharmaceutical Group focused on Manufacturing & Developing API/ HPAPI’s, Advanced Intermediates & Fine Chemicals

Study & Validation of Methods of Analysis

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We provide the study and validation of methods of analysis for the control of the active ingredient and its impurities, in both the raw material and the finished product.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothExperts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

Method Development (Assay, Impurities, Dissol...

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To help you achieve the desired quality and performance of your compound, Recro’s veteran scientists customize solutions for your complex products. Our team adheres to global ICH guidelines to ensure the development of safe, effective, high-quality pharmaceutical products.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothA leading process R&D and API Manufacturing service provider to the Global Pharmaceutical Industry.

Analytic Methods Development & Validation

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ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development and validation, as well as stability testing. All analytical instruments and data are managed through the company's Laboratory Information Management System

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothUnither Pharmaceuticals, a world-leading pharmaceutical contract development manufacturing organization (CDMO)

Method Development

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Unither can provide provide standalone pharmaceutical R&D services such as analytical methods validation, ICH stability studies, clinical batch manufacture, and clinical primary packaging.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothChemistry for a better life

Analytical Method Validation

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Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothEnergise your science for life

Process Optimization FDA Audited

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Dishman's analytical services support both process control and material characterisation for laboratory and production chemistry from initial raw material release to release of the final APIs.

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Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothCommitted to providing Highly Customized Solutions for all your Development Programs.

Analytical Development

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Analytical development (UV/CAD/RID-HPLC, GC, HS-GC), structural characterization (GC-MS, HPLC- MS, NMR, IR)

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothA leading provider of Contract Development and Manufacturing services in softgel advanced technologies for the global market.

Analytical Method Development & Evaluation

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Softigel's seven cutting-edge facilities house a fully integrated PDS unit and covers all product life cycle phases from early development to commercial in the same plant, using equipment replication between non GMP and GMP.

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Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development, Optimization & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development, Validation & T...

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Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Validation 

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Develop & Validate New Analytical Methods

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothUnither Pharmaceuticals, a world-leading pharmaceutical contract development manufacturing organization (CDMO)

Method Validation

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Unither can provide provide standalone pharmaceutical R&D services such as analytical methods validation, ICH stability studies, clinical batch manufacture, and clinical primary packaging.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Optimization, Modernization & Validation of M...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical methods development

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Uetikon offers an extensive expertise to its pharmaceutical and biotechnology partners.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Formulation Validation Support Testing

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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BioReliance® Validation Services

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development & Validation

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Our experienced team are here to deliver your custom small molecule API development projects on time, within budget and to the highest quality standards.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validations

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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ICH Q2 (R1) & cGMP Compliant Method Developme...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Biopharmaceutical Analytical Development

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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CCIT Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Methods Development & Methods Validation

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Validations

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development, Validation & Transfer

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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cGMP Method Validation & Development

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development & Validation of Analytical Method...

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Menadiona's services also can include development and validation of analytical methods, filing of drug master files and regulatory support.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development & Validation of Analytical Method...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Design and Validation of Analytical Method

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The R&D Department is staffed with fully trained and highly experienced scientists and has at its disposal state-of-the-art facilities striving to produce products according to GMP/GLP global standards.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Pharmaceutical Method Development and Validat...

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development & Validation of Diffusion Profile...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Validation of Product Manufacturing Process

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cGMP-conform micronization means having a valid process. We are pleased to offer this service by means of the validation of the product manufacturing process.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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KriSan Biotech offers world class services of new drug process and analytical R&D for small molecules and peptides from Pre-clinical (IND) to Phase II.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Capabilities- Methods Validation &...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Validation & Analysis

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Fermion R&D has over 40 years API development experience. Tacit knowledge is combined into an efficient, standardized development scheme saving time and costs.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development of Analytical Methods for Subsequ...

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Design of a novel synthetic pathway accompanied by supply of a few grams, provision of pilot batches following development of the industrial procedure and GMP production of several tons of product along with regulatory file drafting.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development, Validation & Transfers

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Develops, Validates & Transfers New Methods o...

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Process Validation & Validation of Analytical...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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cGMP Methods Development & Validation

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development of Reliable Analytical Methods

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development, Validation & Transfer

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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Neuland is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry for chemistry related services.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Developing A Method For The Analysis of An AP...

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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Our analytical department is fully compliant with CFR Part II and all in process testing, method development, method qualification and method validation are done in house by our experienced team of analysts and analytical development scientists.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development, Qualification, Validation...

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Chromatographic Method Development & Validati...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Filter Qualification & Validation Studies

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Verification of HPLC Analytical Methods

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method validation & Transfer Activities

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Verification of GC Analytical Methods

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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500 Method Validations in Accordance with ICH...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Validation & Transfer

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FAMAR Technical R&D offers the full range of services for Pharmaceuticals (Rx & OTC) across all dosage forms and Dermocosmetics and Cosmetics (Healthcare & Hygienic). Famar has 4 sites in three countries – France, Greece and Spain.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Validation

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AbbVie Contract Manufacturing offers exceptional end-to-end biologics capabilities with some of the world’s most advanced production facilities.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development, Validation & Transfer

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validations

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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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development & Validation of Analytical Method

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development & Validation of Analytical Method...

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Development of Analytical Methods

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Validation Testing Laboratory

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Test Method Development & Validation

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Pfanstiehl synthesizes proprietary and commercial compounds in quantities ranging from grams to tons. Manufacturing and development take place within a 13-building campus located near Chicago, Illinois.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Evaluation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development, Validation and Support Te...

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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All formulation services can be utilized independently or fully integrated within on-going services at Novick. It includes: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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Design & Validate In-House Methods

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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Pfanstiehl produces proprietary and public domain compounds per cGMP guidelines. From a single kilogram for clinical trials to multi-ton commercial quantities, you can trust Pfanstiehl to help you move your product quickly to market.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development and Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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Chemcon's experience with pharmaceutical requirements and our broad chemical knowledge of small organic molecules, inorganic substances, and polymers allow our analytical team to collaborate with you on tailor-made solutions and analytical packages.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Validation / Verification

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Farmhispania Group offers custom process development and custom manufacturing services for API’s, advanced intermediates and building blocks for the pharmaceutical, biopharmaceutical and related industries.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Development and Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development and Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development, Validation & Transfer

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Method Development & Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation