BioTechLogic’s Tracy TreDenick delivered a very well-received presentation at BPI West 2018 discussing process validation and regulatory strategies for expedited approval drugs. BioTechLogic has done numerous projects supporting clients working to bring therapeutics...
This presentation explores the progress that has been made and the challenges ahead as cellular therapeutics strive to mature in the marketplace. Cellular Therapeutics – Exploring Challenges within the Regulatory Framework
White Paper: 4 Steps for Managing the Criticality and Challenges of Biopharmaceutical Projects Biopharmaceutial project management is a complex process. This SlideShare walks you through the process: Challenges of biopharma project management Scope of...
Combination drug products are complex to both develop and to manage from a compliance perspective. This presentation discusses five critical areas of combination drug compliance including: What is 21 CFR Part 4? FDA’s Office of Combination Products Legacy Combination...
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....
