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Recent Insights

MSATRegulatory Strategy

The Clock Is Running: FDA’s Prior- Knowledge Draft Could Change What Gene Therapy Developers Have to Prove Twice

This article, published in The PDA WCC Insider, was authored by Senior Consultant Patrick Mains.

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MSATQRM

A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies

A recent article titled, “A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies,” written by ValSource Senior Consultants Darius Pillsbury and Tiffany Baker was published in Cell & Gene, Outsourced Pharma, and Bioprocess Online.

This is the first in a series of three articles that will be published.

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Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.