Validation and Qualification Services

Implementing single-use containers, like any new process step, may require validation studies to full characterize the process and ensure product quality. Studies we can help with include:

  • Extractable & Leachable protocol development
  • Stability Studies
  • Physical and Biological Testing
  • Choosing a contract Testing Laboratory
  • Advice on cGMP compliance
  • Change Control documentation management
  • Compliance with CFR 21 parts 11,601 etc.
  • Advice on USP requirements < 87,88, etc. >
  • BPSA Guidance documents
  • PDA and ISPE technical papers

What's New

We are proud to announce that as of June 15, 2017, our management system has been assessed and registered by Intertek as conforming to the requirements of ISO 9001:2015.

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