At the CASSS CMC Strategy Forum in July of this year, BioTechLogic’s Tracy TreDenick, Head of Regulatory and Quality and Senior Consultant, delivered a presentation discussing how to bring legacy combination products into compliance with 21 CFR Part 4. BioTechLogic has a wealth of experience in this area and have successfully helped a number of combination product manufacturers with this very issue. We hope you find the presentation deck to be informative and let us know if we can help you. Also, stay tuned for more on this topic.
BioTechLogic, Inc., is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory resources.
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