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Quality Control & Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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.

Customized Stability & Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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

Raw Material, In-Process & Finished Product Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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.

Quality Control & Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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

Forced Degradation Studies & Stress Tests

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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

Batch Release & Lot Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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

Batch Release & Stability Lot Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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

Product Quality Control & Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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.

In-Process and Lot Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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.

Quality Control Release Testing

Analytical >> Analytical Testing Services >> Batch Release and Stability Lot Testing

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.

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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