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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.

Biolink LifeSciences

BirgiMefar Group

Boston Analytical

CLEARSYNTH LABS LIMITED

CU Chemie Uetikon GmbH

Cambrex Corporation

Capsugel

Cayman Chemical Company Inc

Cebiphar

ChemCon GmbH

ChemWerth Inc

Chromcore Lifesciences

Crenza Pharma

Curida AS

Curtis Health Caps

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

JGL d.d

KriSan Biotech

Labiana Life Sciences S.A

Laboratoires Servier

Lamda Laboratories

Legacy Pharmaceuticals Switzerland

Lubrizol Life Science Health

M2I Life sciences

M2M Pharmaceuticals Ltd

Maithili Life Sciences Private Limited

Malladi Drugs & Pharmaceuticals Limited

Megsan Labs Private Limited

Menadiona

Merck Millipore

Mikart

Mission Pharmacal

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

Proveris Scientific

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

Sai Life Sciences Limited

Saneca Pharmaceuticals

Santa S.A

ScinoPharm Taiwan, Ltd

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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Virtual BoothLeaders in Spray & Aerosol Product Testing and Contract Services.

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Proveris can help every step of the way from formulation & device screening, and method development to regulatory submission & out of specification (OOS) investigations for orally inhaled and nasal drug products (OINDPs).

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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.

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

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ZCL has an analytical development laboratory to support their synthesis group. Major activities include: Analytical method development & validation for RM, WIP & finished products, OVI method development & method validation, impurity profile studies, etc.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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

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Polpharma B2B offers full support from process optimization, analytical method development & validation, to process scale-up dedicated to pilot plant as well as fully commercial, multiple tons synthesis.

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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

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AMRI's laboratory team has extensive experience in designing and executing protocols for analytical 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 BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and Oligonucleotides.

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

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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 BoothGlobal Pharmaceutical Dosage Solutions Company

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual BoothWide range of ophthalmic products, nasal spray, drops along with a variety of contract manufacturing services.

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

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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

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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.

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Temad offers various analytical services such as analytical method 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.

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Wavelength Pharmaceuticals is a world-class developer & manufacturer of active pharmaceutical ingredients (APIs). Their CDMO services include API process development, analytical method development, process optimization & validation, & technology transfer.

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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

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Gentec provides the study and validation of methods of analysis for the control of active ingredient and its impurities, in both raw materials and finished products.

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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

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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

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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.

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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)

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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

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

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

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation