Batch testing

In order to evaluate the Quality, Safety and Efficacy of the given drugs, Quality Assistance offers full capabilities for the control of drug substances, drug products, raw materials and excipients, in the context of in-process control, technical, (non-)clinical and commercial batches.

We provide customised solutions for cGMP batch release testing and test hundreds of QC samples per year. Our qualified teams will work closely with you, dealing with your project and completing all batch documentation to expedite sale, supply and export.

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Batch Testing

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cGMP BATCH TESTING

Extensive QC testing expertise

  • Wide range of physicochemical, biological and microbiological testing for all matrices and products

  • Release testing

  • Back-up storage facilities for your retained samples

  • OOS-OOT procedure compliant with EMA and FDA requirements

RELIABLE ANALYSIS AND REPORTING

  • Certificates of Analysis approved by a Qualified Person (QP).

  • cGMP certified in accordance with EMA/FDA regulations

  • Full command of the regulatory landscape (EMA, FDA, OECD, WHO)

  • Mastery of, and improvement in, our processes & comprehensive quality system

  • Strict day-to-day verification of our results and regular audits of our operations

  • Client orientation to meet their standards and continuously improve our performance