Qualified Person Release

 

 

 

We offer QA release by a Qualified Person of clinical batches and also QP release of drug product to the clinic. We also offer regulatory expertise to support you with IMPD or IND preparation.
 

 

 

As part of our wider service offering, our QPs can release clinical batches under our MHRA IMP license or fully licensed products under a commercial manufacturer/importer’s license. Manufacturing to GMP regulations, we support QP release to clinic, market or direct to you for onward processing.

Our Qualified Person Release Capabilities

  • We can offer QA release by Qualified Person of the clinical batch and also offer QP release of drug product to clinic.
  • We can offer regulatory support for IMPD preparation
  • We can complete the manufacture and subsequent release of drug product within 6 weeks of the date of manufacture.

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