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Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Other services are stability testing by capillary electrophoresis services. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract anlytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Recently, the International Conference on Harmonisation (ICH) regulatory guideline QIA was revised (R2) when QIF “Stability Data Package for Registration Applications in Climatic Zones III and IV” was incorporated. The main changes included: Adjustment of intermediate storage conditions (previously 30°C ± 2°/60% RH ± 5%); acceptable relative humidity was changed to 65% ± 5% for drug substances, drug products and drug products packaged in semi-permeable containers, 30°C ± 2°/65% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/60% RH ± 5% for drug substances and products, 30°C ± 2°/35% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/40% RH ± 5% for drug products packaged in semi-permeable containers. Stability testing is required for all biopharmaceutical drug products to detect all changes in identity, purity, and potency as a result of a number of environmental and processing factors. Whether testing is conducted in-house or through contact laboratories, it involves the development and performance of comprehensive and specific stability protocols for all stages of a product’s life cycle. Testing product stability in-house requires significant time and resources, and carries challenges associated with commercialization market, time, and capacity. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. GMP Stability Services include cGMP registration stability programs, Design, storage and management, Development and validation of stability indicating methods, Stability testing for APIs, Clinical Trial Materials, formulated products, Tailored reporting (timepoint and final reports), All ICH conditions storage, Photostability (ICH Q1B Options 1 & 2), Temperature cycling, freeze-thaw and shipping studies, Bespoke or specialised conditions,Stability contingency and disaster recovery storage etc. Depending upon the aim and steps followed, stability testing procedures have been categorized into the following four types: Real-Time stability testing, Accelerated stability testing, Retained sample stability testing and Retained sample stability testing. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc.

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ACTA Laboratories Inc

AMRI

AVIZ Laboratories

AbbVie Contract Manufacturing

Acceleration Laboratory Services

Admix Pharma Laboratories, LLC

Aenova Group

Aizant Drug Research Solutions Pvt. Ltd.

AlbyPharma

Anacipher

Angelini Pharmaceuticals ACRAF

Arbro Pharmaceuticals Pvt. Ltd

Ash Stevens, Inc.

AvacaPharma

BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

Bachem AG

Bahrain Pharma

BirgiMefar Group

Boston Analytical

CLEARSYNTH LABS LIMITED

Cambrex Corporation

Capsugel

Catalent Pharma Solutions

Cayman Chemical Company Inc

Cebiphar

Century Pharmaceuticals

ChemCon GmbH

Cook Pharmica LLC.

Crenza Pharma

Curida AS

Cyndea Pharma S.L

Dalton Pharma Services

Dannalab B.V

Delorbis Pharmaceuticals LTD

Dishman Carbogen Amcis

Eurofins CDMO

Famar S.A.

Farbe Firma

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

Gracure Pharmaceuticals Limited

JGL d.d

Jubilant HollisterStier

Kimia Biosciences Ltd

KriSan Biotech

Labiana Life Sciences S.A

Laboratoires Servier

LakePharma

Lamda Laboratories

Legacy Pharmaceuticals Switzerland

Lubrizol Life Science Health

Malladi Drugs & Pharmaceuticals Limited

Megsan Labs Private Limited

Merck Millipore

Mithra CDMO

Neopharm Labs Inc

Novick Biosciences

Nutrasource

ORIT LABS LLC

One Pharma S.A

PCI Pharma Services

PSR Pharma Science and Research

PYRAMID Laboratories, Inc

Pace Analytical Services, LLC

Pfanstiehl, Inc

PharmaVize NV

Pharmatis

Primera Analytical Solutions Corp

QUINTA-ANALYTICA s.r.o

Quantex Laboratories

Quotient Sciences

RD Laboratories

Rafarm S.A

Ropack Inc

SEQUENT SCIENTIFIC LTD

STABICON LIFE SCIENCE PVT LTD

Saneca Pharmaceuticals

Santa S.A

ScinoPharm Taiwan, Ltd

Siegfried AG

Softigel Procaps

Sushen Medicamentos Pvt. Ltd

Tepnel Pharma Services

UPM Pharmaceuticals

UQUIFA

Vitas Analytical Services

WellSpring

Wyjolab-Arysta

ZCL CHEMICALS LTD

Zenvision Pharma LLP

mKnal Global Solutions

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Virtual BoothGlobal Pharmaceutical Dosage Solutions Company

Capsules for Stability Studies

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Colorista® is an optimized tool for formulation development enabling compatibility studies before deciding on the final color for the commercial drug products.

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

Stability Studies

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Quality Control Lab is equipped with HPLCs, GC Units with Head space for residual solvents, UV Spectrophotometer, FTIR Spectrophotometer, Particle Size analyzer (Malvern), Polarimeter, Walk-in type Stability Chamber, Modern Microbiological Lab.

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

Stability Studies

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AMRI offers customized accelerated stability studies that includes stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.

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Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and Oligonucleotides.

Stability Studies

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Besides performing all analytical tests demanded by the regulatory authorities for the respective API we also conduct stability studies and test for interactions with packaging materials or other materials that might come into contact with the active.

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

ICH Compliant Stability Control

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We provide ICH compliant stability control with a wide range of ICH conditions of walk in/reach in chambers, refrigerated & freezer storages with fully controlled and monitored.

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Virtual BoothTransforming Drug Development with Science & Innovation.

ICH Stability Testing of Drug Products

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We have extensive experience in the testing of drug products including preclinical prototype evaluation, Excipient compatibility, Finished product testing including purity, dissolution, physical characterization ICH stability testing of drug products.

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

Stability Studies

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Malladi’s R&D is well-equipped with a wide range of process and analytical capabilities such as method development and validation, stability including stability studies, photostabiltiy studies, stress testing and degradation profiling.

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Virtual BoothPharmaceutical Group focused on Manufacturing & Developing API/ HPAPIs & Fine Chemicals

ICH Stability Studies

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Gentec Pharmaceutical Group offers API, intermediates and HPAPIs developments and manufacture. We perform ICH stability studies on drug substance for our customers.

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

Stability Studies/Forced Degradation Studies

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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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Virtual BoothYour Drug Development partner of drug substance/API and Drug Product Operations for biologics and small molecules.

Stability Studies

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We perform ICH compliant stability studies including stress studies, accelerated and long-term stability studies to support regulatory CMC programs and process development.

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

Stability Studies for Bulk APIs/Formulations

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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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Virtual BoothChemistry for a better life

Stability Studies

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

ICH Stability Studies

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Our R&D services include Drug substance, clinical trial materials, IND, NDA & ANDA registration stability testing, All ICH climatic stability zones, Photostability chamber, Forced degradation studies, Computerized data management & pull schedules, etc

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Virtual BoothGMP APIs & Flow Chemistry from a Leader in the Healthcare & Wellbeing market in the Pharma & Mass-market sectors

Stability Conditions

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Your GMP “One-Stop-Shop”, Angelini Fine Chemicals is a Contract Development and Manufacturing Organization (CDMO), which is fully dedicated to third party manufacturing of APIs, IMs and NCEs for the pharmaceutical and small molecule biotech industry.

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Virtual BoothAPI Manufacturer for over 30 years & Partner of choice for multipurpose custom manufacturing projects

Stability Studies

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We are undertaking contracts for Stability studies for APIs and Biotechnology products under various temperature conditions.

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Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

ICH Stability Studies

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We perform ICH stability studies on drug substance and /or dosage form. Studies are conducted according to the Stability Study Protocols and fully under GMP conditions.

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Stability Testing and Storage

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With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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Stability Studies

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Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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Stability Testing

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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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Stability Studies

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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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Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

Stability Studies

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Since its foundation, Quinta-Analytica has been providing a complete service of stability studies with active substances and dosage forms. Also these studies are conducted within the GMP framework and according to the ICH guidelines.

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ICH-Compliant Stability Studies

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Each of our plants has qualified in-house climate chambers and can do ICH-compliant stability studies, using carefully set conditions depending on product characteristics, regulatory requirements and the desired shelf life.

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Stability Storage For all key ICH climatic zo...

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Offering stability storage for all key ICH climatic zones. Our available conditions and storage solutions are suitable for long term, intermediate, accelerated, photo-stability, in-use and FUST stability trials.

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Stability Studies

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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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Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

Stability Cabinets

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Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Stability Cabinets - temperature/humidity/light exposure testing compliant with ICH guidelines.

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Stability Test

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CLEARSYNTH efforts focus from the pre-clinical stage through to phase III and to the successful technology transfer to manufacturing locations throughout the world.

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Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

Stability Chambers

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Quinta is an established provider of multiple R&D and regulatory services for pharmaceutical, biotechnology and generic drug industries. Stability Chambers - 25°C/60%; 30°C/65%; 30°C/75%, 40°C/75%, 5°C and others compliant with ICH guidelines.

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Stability Testing

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We have a dedicated stability and analysis group at our laboratory, Diteba, providing comprehensive support for all stages of drug development, including early research and development to commercial or post-approval studies.

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Stability Studies

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We have a well-equipped laboratory and are capable of handling wide variety of all generic injectable formulations. In addition, we are well equipped to conduct stability studies right from the lab scale through the commercial scale.

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Stability Storage & Testing

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Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

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Stability Studies

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Kimia's state of the art manufacturing facility is manufacturing latest (R&D based) & generic (regular) Bulk Drugs and Advance intermediates.

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Pharma Service: Analytical

Category: Stability Studies

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