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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

Arcinova

Arevipharma GmbH

Ascent Innovative Medicines

Ash Stevens, Inc.

AvacaPharma

Avivia

BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

Bachem AG

Basic Pharma

Bio-Technology General Israel Ltd.

BirgiMefar Group

Boston Analytical

CLEARSYNTH LABS LIMITED

CU Chemie Uetikon GmbH

Cambrex Corporation

Capsugel

Cayman Chemical Company Inc

Cebiphar

ChemCon GmbH

ChemWerth Inc

Crenza Pharma

Curida AS

Cyndea Pharma S.L

DPT Laboratories, Ltd

Dishman Carbogen Amcis

Diverchim S.A.

Etico Lifesciences

Evotec

Famar S.A.

Farmhispania, S.A.

Flagship Biotech International Pvt. Ltd

Fresenius SE & Co. KGaA

GALENIX INNOVATIONS

GALIEN LPS

GRAM Laboratory Inc

GVK Biosciences

Gentec Pharmaceutical Group

Globela Pharma

KriSan Biotech

Labiana Life Sciences S.A

Lamda Laboratories

Legacy Pharmaceuticals Switzerland

Lubrizol Life Science Health

M2I Life sciences

M2M Pharmaceuticals Ltd

Madras Pharmaceuticals

Maithili Life Sciences Private Limited

Malladi Drugs & Pharmaceuticals Limited

Megsan Labs Private Limited

Menadiona

Merck Millipore

Mithra CDMO

Neopharm Labs Inc

Neuland Laboratories

Novick Biosciences

Nutrasource

ORIT LABS LLC

Olive Healthcare

One Pharma S.A

PCI Synthesis

PSR Pharma Science and Research

PYRAMID Laboratories, Inc

Pace Analytical Services, LLC

Pfanstiehl, Inc

PharmaVize NV

Polpharma

Progenerics Pharma Pvt Ltd

QUINTA-ANALYTICA s.r.o

Quantex Laboratories

RD Laboratories

RECRO GAINESVILLE

Rafarm S.A

Recipharm AB

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

Solara Active Pharma Sciences

Stason Pharmaceuticals, Inc.

Sushen Medicamentos Pvt. Ltd

Temad Co

Tepnel Pharma Services

UQUIFA

Unither Pharmaceuticals

Vitas Analytical Services

Wavelength Pharmaceuticals

ZACH SYSTEM SA

ZCL CHEMICALS LTD

Zenvision Pharma LLP

mKnal Global Solutions

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CHINA

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CZECH REPUBLIC

FRANCE

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INDIA

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ISRAEL

NETHERLANDS

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TURKEY

UNITED KINGDOM

UNITED STATES

Virtual BoothEuropean generic drug manufacturer/ API Supplier/ 6 manufacturing sites/ 5 R&D Centers/ 700 products & 250 under development.

Method Development and Validation

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We provide full analytical support including Analytical Method Transfer, Analytical Method Validation in accordance with ICH guidelines, Quality control & Release testing of raw materials & FDFs, Stability studies in different ICH storage conditions, etc

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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 Method Development & Validation

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Skyepharma offers various analytical services such as method development and validation, process optimization & continuos process monitoring. They also offer registration and commercial stability study, microbiological and chemical testing.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothGeneric API development & supply// Non-infringement patent strategies development// Regulatory support.

Method Development & Validation

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Through ChemWerth’s own laboratory, we can provide analytical services from methods development to methods validation.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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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We have a dedicated analytical development laboratory to support the synthesis group. Our major activities - Analytical method development & validation, for RM, WIP & Finished Products, OVI method development & Method validation, Impurity profile studies

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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 — covering procedures for APIS, formulations, cosmetics, and raw materials etc.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothSpecializes in development of innovative, efficient manufacturing processes & reliable production of peptide-based APIs

Method Development & Validation

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Bachem constantly develops and validates new analytical methods, aiming at setting industrial standards in the analysis of peptides.

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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 BoothWe think of World Class Quality.

Method Development and Validation

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Temad offers various analytical services such as Method of Analysis Development & Validation, Identification, Separation, Physical & Chemical characterization of impurities based on the latest pharmacopeias, Issuance of impurity profile etc.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothWorld-Class Developer & Manufacturer of Differentiated APIs// in 50 countries// 198 DMFs Worldwide.

Method Development and Validation

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We support your API development & manufacturing requirements. Our CDMO Services include technology transfer, process development, analytical methods development, synthesis of impurities & standards, potential genotoxic impurities evaluation etc

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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/ HPAPIs & 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

Virtual BoothEurope's most reliable and versatile source for Prostaglandin APIs// FDA Inspected 2017

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 and Validation

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Recro provides various analytical testing services including raw material, in-process & finished product release testing, physiochemical characterization, method development & validation (assay, impurities, dissolution, cleaning), residual solvents by GC.

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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 & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

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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 and Validation

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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.

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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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothEnergise your science for life

Method Development & Validation

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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.

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Pharma Service: Analytical

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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Our 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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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothYour Contract Manufacturing Partner for all Dosage Forms & Global Market

Method Development & Validation

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Our analytical development capabilities include Development & Validation of analytical test procedures for Assay, Content Uniformity, Dissolution, Related Substances, Residual Solvents, other in-house test procedures & Finalization of Specifications.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothBrightest Minds in the CDMO industry - From early Development to Commercial Manufacturing

Method Development and Validation

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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.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothAPI Expertise for more than 30 Years, with 4 Manufacturing Facilities armed with Global Approvals.

Method Development and Validation

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothGlobal Pharmaceutical Dosage Solutions Company

Method Development and Validation

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Capsugel provides full analytical development & validation in support of formulations for clinical-trial materials & commercial products.

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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

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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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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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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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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

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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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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 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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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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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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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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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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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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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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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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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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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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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 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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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 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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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 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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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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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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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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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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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 a