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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

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

LakePharma

Lamda Laboratories

Legacy Pharmaceuticals Switzerland

Lubrizol Life Science Health

Madras Pharmaceuticals

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

Polpharma

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

Servier CDMO

Siegfried AG

Softigel Procaps

Sushen Medicamentos Pvt. Ltd

Tepnel Pharma Services

UPM Pharmaceuticals

UQUIFA

Vitas Analytical Services

Wavelength Pharmaceuticals

WellSpring

Wyjolab-Arysta

ZCL CHEMICALS LTD

Zenvision Pharma LLP

mKnal Global Solutions

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CANADA

COLOMBIA

CROATIA

CYPRUS

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INDIA

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ISRAEL

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NETHERLANDS

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United States

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

Stability Studies

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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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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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Pharma Service: Analytical

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

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

Stability Studies

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We support your API development & manufacturing requirements. Our CDMO Services include Solid State / Polymorphism Research, Characterization of Physical Properties, Particle Design, cGMP scale Up, Process Validation, Stability Studies etc

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Pharma Service: Analytical

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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 BoothEnergise your science for life

ICH Stability Studies/Degradation Profiling

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Dishman offers various analytical services under Stability which includes ICH Stability Studies, Stressing Studies, Photostability Studies, Drug Substance & Drug Product Stability and Degradation profiling.

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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 BoothYour Contract Manufacturing Partner for all Dosage Forms & Global Market

Stability Studies as per ICH Guideline

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The Formulation R & D Capability includes Design and development of new dosage forms, Pre formulation studies, Lab / pilot scale studies, Process optimization/validation studies, Stability studies as per ICH guidance, Technology transfer of new products.

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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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Category: Stability Studies

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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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Pharma Service: Analytical

Category: Stability Studies

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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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Pharma Service: Analytical

Category: Stability Studies

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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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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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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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Category: Stability Studies

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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 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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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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Category: Stability 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 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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Pharma Service: Analytical

Category: Stability Studies

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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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Pharma Service: Analytical

Category: Stability Studies

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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

Sub Category: Overview

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Stability Studies as per ICH Guideline

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Gracure's facility has capability to manufacture tables, hard gelatin capsules, oral liquids, dry powder syrups, and ointments. The facility is designed for serving International market.

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Pharma Service: Analytical

Category: Stability Studies

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Stability Studies

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

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Pharma Service: Analytical

Category: Stability Studies

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Stability Studies

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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: Stability Studies

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ICH compliant Stability Programs

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Our scientists at WellSpring have years of experience using advanced analytical equipment to ensure precision during all our testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards.

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Pharma Service: Analytical

Category: Stability Studies

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cGMP Compliant Stability Study Protocols

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ACTA can write stability protocols for you or provide assistance to ensure your stability projects are fully cGMP compliant and meet the stringent requirements of the FDA. ACTA tracks your stability projects carefully to ensure that they are tested in a timely manner.

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Pharma Service: Analytical

Category: Stability Studies

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SAXS for Stability Studies

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Information about the structural parameters obtained from the SAXS measurements, such as envelope shape and invariants (mass and radius of gyration), serve as important markers that are correlated with biological activity.

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Pharma Service: Analytical

Category: Stability Studies

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Long-Term, Intermediate & Accelerated ICH Sta...

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At DELORBIS, we are equipped with stability chambers that enable us to conduct ICH stability studies at long-term, intermediate and accelerated conditions.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Solid-State & Solution-State Stability

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Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules.

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Category: Stability Studies

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Stability and Shelf Life Services

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Quantex Laboratories offers a complete range of stability testing services to assist you with your stability testing requirements. We have numerous temperature and humidity conditions available in our qualified stability storage chambers, including all conditions needed to comply with the ICH

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Pharma Service: Analytical

Category: Stability Studies

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Full ICH Stability Conditions

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UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Drug-Substance Stability Testing

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Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

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Category: Stability Studies

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Stability Studies In ICH Guideline-Chambers

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Our GMP-compliant facility is fully equipped to conduct stability tests throughout the development process (real or accelerated) or on-going tests. Wyjolab offers large, climate-controlled storage facilities that comply with ICH guidelines.

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Stability Testing

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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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Category: Stability Studies

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ICH & On-Going Stabilities

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Pharmatis has been conceiving and developing various recipes, processes and drugs for many years. Pharmatis offers a wide range of industrial developments.

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Category: Stability Studies

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Stability Studies

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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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Category: Stability Studies

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ICH Q3B Compliant Stability or Forced Degrada...

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We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions, Which includes bulk holding time, Freeze/thaw studies, Informal, formal, accelerated and long-term stability conditions & ICH or custom conditions.

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Pharma Service: Analytical

Category: Stability Studies

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Stability Studies

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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: Stability Studies

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Stability Testing for Finished Products

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Bahrain Pharma have excellent analytical services including stability testing for finished products, raw materials, in process materials and other Pharmaceutical or Nutraceutical materials.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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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Pharma Service: Analytical

Category: Stability Studies

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Stability Studies - Stress Test Studies

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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: Stability Studies

Sub Category: Overview

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Stability Storage & Testing

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PCI features fully audited, in-house laboratories in both our European and North America locations offering a range of analytical services to support clients in the development and commercialization of new medicines.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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ICH Stability (5° C, 25° C/60% RH, 30° C/6...

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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: Stability Studies

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Stability Testing

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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: Stability Studies

Sub Category: Overview

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Comparative Stability

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Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

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Pharma Service: Analytical

Category: Stability Studies

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ICH Stability Testing

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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: Stability Studies

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Stability Studies

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Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Formulation Evaluation Stability Testing

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Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Stability Testing

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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: Stability Studies

Sub Category: Overview

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ICH Stability Studies

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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: Stability Studies

Sub Category: Overview