Batch testing

Quality Assistance offers a comprehensive range of physicochemical, biological and microbiological QC testing.

We are your one-stop shop for the control of raw materials, excipients, Drug Substances and Drug Products in the context of in-process control, technical, (pre-)clinical and commercial batches.

All of our Certificates of Analysis are approved by a Qualified Person.

Download the brochure

Batch Testing

Download

Our expertise

Customer support

  • Analytical testing of all materials and products, on one site
  • Batch testing services for all matrices
  • T0 for stability studies
  • Compendial testing in accordance with Ph. Eur. , USP-NF and JP
  • Back-up storage facilities for your retained samples
  • OOS-OOT procedure compliant with FDA requirements
  • Certificates of Analysis approved by a Qualified Person

Analytical techniques

  • Separative techniques
  • Mass spectrometry
  • Elemental analysis
  • Size / particles analysis / size distribution
  • Spectroscopy and optical measurements
  • Titration
  • Physical testing
  • Molecular biology, ELISA and binding
  • Cell culture and bioassay