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Product release testing, also known as lot or batch release testing is an important step in the quality control process of drug substances and drug products. This testing verifies that a pharmaceutical or biopharmaceutical product meets a pre-determined set of specifications. These often include verification of the formulation’s identity, potency and purity, impurities, uniformity, identity, presentation attributes, and sterility. Products that require Release Testing to meet GMP compliance are: Raw drug substance materials & drug products that are to be used in clinical trials, Raw & in-process materials used in commercial production, Marketed products, Validation batches developed for utilization in an ICH stability study, etc. Contract Pharma Analytical service providers can develop, validate, and transfer even the most sophisticated analytical methods. They provide an accurate analysis of time-sensitive products that are under development to ensure that they can be quickly approved for release and distribution into the commercial marketplace. Good Manufacturing Practice (GMP) batch release testing is a necessary requirement to ensure high quality pharmaceuticals and biopharmaceuticals prior to release for sale, supply or export. Whilst a pharmaceutical company focuses on its core business activities, it also needs to select a partner who can assist with strong regulatory compliant batch release testing to a consistently high standard. The batch release testing teams utilise a wide range of analytical technologies to provide responsive release testing to ensure that healthcare products meet the product specification within the Marketing Authorisation (MA) or Clinical Trial Dossier (CTD). Batch release testing expertise includes chemical, physical and biological testing (including pharmacopeia analysis methods (BP, EP, JP and USP)). Our teams, based in our GMP compliant analytical laboratories, routinely work with clients around the globe to ensure that appropriate method transfer is performed.

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AMRI

Admix Pharma Laboratories, LLC

Aenova Group

Ash Stevens, Inc.

Basic Pharma

Boston Analytical

CARBOGEN AMCIS AG

Cebiphar

ChemCon GmbH

DPT Laboratories, Ltd

Delorbis Pharmaceuticals LTD

GVK Biosciences

Jubilant HollisterStier

KriSan Biotech

Megsan Labs Private Limited

Mithra CDMO

ORIT LABS LLC

PHARMATHEN INDUSTRIAL SA

PYRAMID Laboratories, Inc

Pace Analytical Services, LLC

QUINTA-ANALYTICA s.r.o

Quantex Laboratories

RECRO GAINESVILLE

ScinoPharm Taiwan, Ltd

Stason Pharmaceuticals, Inc.

Tepnel Pharma Services

Unither Pharmaceuticals

Vitas Analytical Services

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

Quality Control & Release Testing

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- Service Details

Quinta-Analytica is a well-known and established company performing so called „import testing“. This is a testing of a batch manufactured outside EU which is planned for import and release within European market.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

Customized Stability & Release Testing

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- Service Details

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

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Virtual BoothExperts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

Raw Material, In-Process & Finished Product R...

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To help you achieve the desired quality and performance of your compound, Recro’s veteran scientists customize solutions for your complex products. Our team adheres to global ICH guidelines to ensure the development of safe, effective, high-quality pharmaceutical products.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

Quality Control & Release Testing

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- Service Details

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

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

Pharmaceutical Release

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- Service Details

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

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Forced Degradation Studies & Stress Tests

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CARBOGEN AMCIS' forced degradation studies and stress tests encompass stress testing under acid or alkaline conditions, oxidative stress testing, and photostability studies. Based on the innovator’s specific needs, we can develop and tailor stability studies as well as forced degradation

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Batch Release & Lot Release Testing

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Tepnel Pharma Services is an approved and accredited QC testing laboratory with a long history of batch release and lot release testing. We provide a wealth of experience across a wide range of small molecule, inhaled products and biopharmaceutical product types in accordance with the requirements

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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

Batch Release & Stability Lot Testing

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- Service Details

AMRI provides the resources and flexibility to develop and improve analytical methods tailored to your specific needs.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Product Quality Control & Release Testing

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Quantex Laboratories supports your product Quality Control and Release Testing needs for Active Ingredients intermediates, excipients and finished products. We have experience testing for many types of formulations.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Quality Control Release Testing

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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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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In-Process and Lot Release Testing

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- Service Details

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Stability Testing & Storage Support

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- Service Details

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Stability Batch Testing & Stability Evaluatio...

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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EU Batch Testing & Release

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DELORBIS also offer services such as EU batch testing and release of pharmaceutical products.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Finished Product Release

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- Service Details

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Commercial Release Testing

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- Service Details

Orit Laboratories comprises of analytical testing laboratories and formulation development areas operating under cGLP and cGMP. Orit has a number of products already approved and marketed, with several additional products already filed and under FDA review.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Release of Quality Control Data

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Vitas has a manufacturing authorization for medicinal products (Quality Control testing). Vitas has internal procedures for release of Quality Control data on samples covering the range from clinical trial to medicinal products offered for sale.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Test & Release of Starting Materials & Final ...

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Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Establish Specifications & Release Testing

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KriSan Biotech helps to establish specification for raw materials, intermediates, and APIs as well as release testing.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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GMP Batch Release Testing

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- Service Details

Pharmathen’s offers cGMP Quality Control (QC) testing for excipients, intermediates, raw materials, APIs and GMP batch release testing for drug products supporting pharmaceutical development and manufacturing.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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ICH Stability Testing & Storage

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- Service Details

Pharmathen’s offers cGMP Quality Control (QC) testing for excipients, intermediates, raw materials, APIs and GMP batch release testing for drug products supporting pharmaceutical development and manufacturing.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Release Testing of Incoming Materials / Finis...

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- Service Details

Our mission is to support you in the compliance of your products by providing quality control analysis services as part of validation and release of production batches.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Batch Release Testing

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- Service Details

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

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Testing & Release of API & excipients

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- Service Details

Aenova offers testing and release of active pharmaceutical ingredients and excipients according to monograph or customer specifications

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Raw Material, In-Process and Final Product Re...

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PYRAMID has over 4,000-sq. ft. of dedicated laboratory area with state of the art equipments. PYRAMID is a FDA registered Facility. All analyses are performed according to the applicable GLP and cGMP guidelines and regulations as documented in the Code of Federal Regulations (CFR) Title 21.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Batch Review & Release

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- Service Details

Basic Pharma supports in setting up a full and structured Quality Management System tailored to your company’s individual needs.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Batch Release & Stability Lot Testing

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- Service Details

We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Lot Release & Stability Assessment

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- Service Details

Analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. We also have a DEA analytical permit for CII-CIV products.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Finished Product Testing & Release

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- Service Details

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.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Release analysis

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- Service Details

ChemCon’s analytical department performs comprehensive release analysis of your cGMP material. For GMP analytics, our independent Quality Assurance team verifies the results and provides release certificates.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Release & In-Process Testing

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- Service Details

GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Batch Reslease & Stability Lot Testing

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- Service Details

Cebiphar' services, among others, is the analysis of your samples during pre and post MA stability studies (all ICH-VICH conditions, stress testing studies, photostability studies, transport studies) and batch release testing of your FDFs.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

Product release testing, also known as lot or batch release testing is an important step in the quality control process of drug substances and drug products. This testing verifies that a pharmaceutical or biopharmaceutical product meets a pre-determined set of specifications. These often include verification of the formulation’s identity, potency and purity, impurities, uniformity, identity, presentation attributes, and sterility. Products that require Release Testing to meet GMP compliance are: Raw drug substance materials & drug products that are to be used in clinical trials, Raw & in-process materials used in commercial production, Marketed products, Validation batches developed for utilization in an ICH stability study, etc. Contract Pharma Analytical service providers can develop, validate, and transfer even the most sophisticated analytical methods. They provide an accurate analysis of time-sensitive products that are under development to ensure that they can be quickly approved for release and distribution into the commercial marketplace. Good Manufacturing Practice (GMP) batch release testing is a necessary requirement to ensure high quality pharmaceuticals and biopharmaceuticals prior to release for sale, supply or export. Whilst a pharmaceutical company focuses on its core business activities, it also needs to select a partner who can assist with strong regulatory compliant batch release testing to a consistently high standard. The batch release testing teams utilise a wide range of analytical technologies to provide responsive release testing to ensure that healthcare products meet the product specification within the Marketing Authorisation (MA) or Clinical Trial Dossier (CTD). Batch release testing expertise includes chemical, physical and biological testing (including pharmacopeia analysis methods (BP, EP, JP and USP)). Our teams, based in our GMP compliant analytical laboratories, routinely work with clients around the globe to ensure that appropriate method transfer is performed.

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