BioTechLogic’s Tracy TreDenick delivered a very well-received presentation at BPI West 2018 discussing process validation and regulatory...
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Cellular Therapeutics – Exploring Challenges within the Regulatory Framework
This presentation explores the progress that has been made and the challenges ahead as cellular therapeutics strive to mature in the marketplace. Cellular Therapeutics...
5 Critical Areas of Combination Drug Compliance
Combination drug products are complex to both develop and to manage from a compliance perspective. This presentation discusses five critical areas of combination drug...
Bringing Legacy Combination Products into Compliance with 21 CFR Part 4
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...
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