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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

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

Bahrain Pharma

BirgiMefar Group

Boston Analytical

CLEARSYNTH LABS LIMITED

Cambrex Corporation

Catalent Pharma Solutions LLC

Cayman Chemical Company Inc.

Cebiphar

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

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

Globela Pharma Pvt. Ltd.

Gracure Pharmaceuticals Limited

JGL d.d

Jubilant HollisterStier

Kimia Biosciences Ltd

KriSan Biotech

Labiana Life Sciences S.A

LakePharma

Legacy Pharmaceuticals Switzerland

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

Particle Sciences

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.

Servier CDMO

Siegfried AG

Softigel Procaps

Sushen Medicamentos Pvt. Ltd

Tepnel Pharma Services

UPM Pharmaceuticals

UQUIFA

Unither Pharmaceuticals

Vitas Analytical Services

WellSpring

Wyjolab-Arysta

ZCL CHEMICALS LTD

Zenvision Pharma LLP

mKnal Global Solutions

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CROATIA

CYPRUS

CZECH REPUBLIC

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GERMANY

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INDIA

IRELAND

ITALY

NETHERLANDS

NEW ZEALAND

NORWAY

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SLOVAKIA (SLOVAK REPUBLIC)

SOUTH AFRICA

SPAIN

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

Nordic Life Science Days

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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Pharma Service: Analytical

Category: Stability Studies

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Virtual Booth 100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

Pharma ChemOutsourcing

Walk-in type Stability Chamber

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Well-equipped laboratories performing comprehensive tests for the finished products, WIP, raw materials, equipment cleaning in compliance to ICH guidelines using Pharmacopoeial methods, In-house test methods and customer's requirements.

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Pharma Service: Analytical

Category: Stability Studies

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

ICH Compliant Stability Control

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A wide range of ICH conditions of walk in/reach in chambers, refrigerated and freezer storages which are fully controlled and monitored. 24 hour alarm system is on site, along with a dedicated team trained to respond to any deviations from the set storage conditions.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Virtual Booth Transforming Drug Development with Science & Innovation.

American DDF Summit

ICH Stability Testing of Drug Products

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We offer a full stability storage and testing service that satisfies ICH guidelines for the stability assessment of your drug products.

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Pharma Service: Analytical

Category: Stability Studies

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

CPhI Worldwide

Booth No. 40K20

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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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Pharma Service: Analytical

Category: Stability Studies

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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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Pharma Service: Analytical

Category: Stability Studies

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Virtual Booth Offering Full Spectrum of services from early stage of synthesizing potential NCE's to Large-Scale Commercial Operation.

CPhI Worldwide

Booth No. 40C20

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Stability Studies for Bulk APIs & Formulation...

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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

Contract & Outsourcing Conference

ICH Stability Studies with Storage

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

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Pharma Service: Analytical

Category: Stability Studies

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Virtual Booth Chemistry 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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Pharma Service: Analytical

Category: Stability Studies

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Virtual Booth Energise your science for life

ICH Stability Studies/Degradation Studies

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

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Pharma Service: Analytical

Category: Stability Studies

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ICH Stability Studies

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

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Pharma Service: Analytical

Category: Stability Studies

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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

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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

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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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Pharma Service: Analytical

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

Nordic Life Science Days

Accelerated & Forced Degradation Studies

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Our team has carried out FDS not only within the development of new methods, we have also designed and performed FDSs within a GMP validation of methods in cooperation with the department of pharmaceutical analysis.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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

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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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Pharma Service: Analytical

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Sub Category: Overview

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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Pharma Service: Analytical

Category: Stability Studies

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

Nordic Life Science Days

Capillary Electrophoresis for Stability Studi...

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Quinta is one of the capillary electrophoresis service providers for stability studies. Quinta's analytical stability testing by capillary electrophoresis are conducted according to ICH stability study protocols for testing APIs and drug products. Quinta also offers analytical stability studies

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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Pharma Service: Analytical

Category: Stability Studies

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

Nordic Life Science Days

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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Pharma Service: Analytical

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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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

Sub Category: Overview

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

Nordic Life Science Days

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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Pharma Service: Analytical

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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

ICH Compliant Stability Studies (Storage & Te...

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

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Pharma Service: Analytical

Category: Stability Studies

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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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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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Stability Studies

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

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Category: Stability Studies

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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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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

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

Sub Category: Overview

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

Sub Category: Overview

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

Sub Category: Overview

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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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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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

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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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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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 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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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Our researchers executes every phase of the development process with the utmost care, including identification of reliable suppliers of active ingredients, realization of laboratory and industrial-scale trial batches, development and validation of analytical methods and stability studies.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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

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

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

Sub Category: Overview

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

Sub Category: Overview

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

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 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

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

SLOVAKIA (SLOVAK REPUBLIC) Slovakia (slovak Republic)


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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

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

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Stability Studies

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KriSan Biotech offers stability studies for bulk active ingredients and preparation of regulatory documentation, including chemistry manufacturing and control sections of investigational new drug applications.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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

Stability-Indicating Method Validation Servic...

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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

GLP Stability Studies

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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

Sub Category: Overview

Current ICH & Custom Condition Stability Stor...

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Pace Analytical Life Sciences provides ICH and custom storage as well as analytical services for your cGMP stability programs. PLS offers long and short-term (accelerated) stability services for R & D and commercial products, as well as personalized project management assistance.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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Additionally, Curida offers following services across all technologies: Stability studies

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH Stability Studies

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We inspect and test for all standard climate zones according to the guidelines of the International Conference on Harmonisation (ICH).

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH-Compliant Stability Studies

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Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

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Pharma Service: Analytical

Category: Stability Studies

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Conducting Stability Studies

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Flagship biotech had established A state-of-art Research and Development Centre (R&D) at Mumbai - focused towards developing new products, improving existing products as well as drug delivery systems and expanding product applications.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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Servier brings 60 years of experience in process development, intermediates, APIs and high-potency APIs. Our full cGMP?/?FDA-approved chemistry network includes R&D, production and supply chain expertise with full regulatory support.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Release & Stability Testing

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Catalent's stability services focus on the delivery of quality stability data to support every stage of the product development lifecycle. Our stability studies support all phases of drug development.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies for Shelf Life Estimation

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Stability testing is integral to developing new pharmaceutical products and active pharmaceutical ingredients, to establish their shelf life or expiry date. We provide a complete solution to your requirements of Stability Studies for Shelf Life Estimation.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Forced Degradation Studies - Acid, Base, Heat

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GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies of Liquid or Lyophilized Fo...

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Cook Pharmica product development organization develops processes, methods and formulations that support and improve the manufacturability and stability of our clients’ products. From early cell culture scientists to analytical specialists.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stereochemical Stability

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We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Storage Chambers

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R.D. Laboratories, Inc. has an extensive array of GC capabilities. Because of our extensive experience and capabilities, customers rely on us for all of their compedial residual solvents testing, client specific methods and residual solvent validations.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Chemical & Physical Stability of Polymorphs

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We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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At PSR we have a dedicated group of qualified personnel to conduct stability studies of drug products and substances in compliance with ICH guidelines.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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Curida offers services within storage, monitoring, and analytical testing and documentation. We have several climatic chambers available, such as cold and cool storage rooms.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Narcotics Stability Studies

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Neopharm offers a full range of stability testing and storage services to meet the performance needs of our clients. Our stability operations include 15,000 cubic feet of walk-in/reach-in chambers/incubators that meet the ICH guidelines requirements.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH & FDA Compliant Stability Testing For Dru...

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Our stability samples are housed in ICH compliant storage chambers. All chambers and rooms are mapped, monitored for temperature and humidity, alarmed, and backed up with emergency power to ensure accurate results.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Aging Studies

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Pace Analytical Life Sciences (PLS) is a full-service contract testing laboratory providing physical and functional testing services to the pharmaceutical and medical device industries.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Residual Moisture Stability Studies

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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability-Indicating Assay

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From early strategic investigative work on possible formulations to the development and implementation of methods and the generation of regulatory submission data, our team of experienced scientists will work – and communicate – with you at every step.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Zeta Potential Determination

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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Static Decay Testing

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Pace Analytical Life Sciences (PLS) is a full-service contract testing laboratory providing physical and functional testing services to the pharmaceutical and medical device industries.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH compliant Stability Programs

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Our ICH stability storage facilities consist of over 100 m3 of walk-in stability rooms, fully secured with 24/7 electronic monitoring, alarm and backup power.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Suspension & Emulsion Stability Studies

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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Statistical Analysis of Stability Data

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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability of Standard Preparations

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GRAM Laboratories offers all analytical methods are validated as per the ICH guidelines. Compendial methods when used for analysis of stability samples are also validated as per ICH guidelines. The following parameters are challenged during the validation process.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability of Sample Preparations

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GRAM Laboratories offers all analytical methods are validated as per the ICH guidelines. Compendial methods when used for analysis of stability samples are also validated as per ICH guidelines. The following parameters are challenged during the validation process.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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Stability studies for drug substances and drug products according to ICH requirements; performed in our own qualified stability chambers, compatibility studies of binary or complex mixtures of API(s) with excipient(s) performed to Support early development phases.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Testing

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Stabicon offer Stability Study Services to support all phases of Drug Development.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH Stability Studies

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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Analytical research and development (AR&D) offers standalone services and supports our formulation development activities. Aizant offers GLP compliant ICH stability testing services.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Forced Degradation Studies

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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AbbVie Contract Manufacturing's pharma contract manufacturing services support material procurement, process optimization, formulation, validation and analytics testing.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Analysis of Drug Products

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LakePharma utilizes CE-SDS, SEC-HPLC, DSC, intact mass, peptide mapping, and cIEF assays to examine the integrity and stability of antibodies under different conditions. A wide variety of storage conditions can be tested, including temperature, cryoprotectants, and antioxidants.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Testing

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Our leading competence centers provide a variety of services, including stability testing and the creation of stability reports, storage, and optimizing production methods. We plan studies designed according to ICH guidelines1.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Testing

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Testing

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Accelerated & Long Term Stability Studies

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Aviz Labs, together with specialized partners, is able to assist clients needing stability and testing studies conducted. The results of such testing not only provides customers with the confidence that a quoted lifespan can be realistically achieved.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH Stability Studies of Active Substances

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In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries and provides ICH stability studies of active substances.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH Stability Studies

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We are equipped with dedicated facilities to perform full stability studies, according to the latest ICH and FDA recommendations, and following the requirements for Climatic Zones I, II, III and IV.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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PYRAMID understands the importance of accuracy, integrity, timeliness and compliance for all stability study programs. Our stability services are proven reliable for pilot formulations, clinical batches and marketed products. Our controlled storage area accommodates all ICH storage conditions.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH Conditions Stability Studies

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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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Cyndea Pharma focuses its efforts on the development and manufacturing of generic drugs with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with high activity products.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

ICH Compliant Stability Testing

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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All formulation services can be utilized independently or fully integrated within on-going services at Novick. These include - Accelerated Stability Studies, Intermediate Stability Studies, Long Term Stability Studies

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Study Development According to ICH ...

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Jubilant HollisterStier’s innovative microbiological and analytical labs are operated by experienced professionals using the most current equipment and procedures to ensure seamless technical transfer of analytical methods for our clients.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stress & Stability Studies

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ChemCon carries out ICH-compliant stress and stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

Stability Studies

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

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview