Clear CMC strategy.
Confident regulatory readiness.

I founded BioLicensure LLC after spending more than 20 years in “big pharma” and “small biotech” concentrating on regulatory affairs, technical writing, CAPA development and tracking, GMP training, and inspection readiness. I’ve been really lucky in that my career led me through so many aspects of development and commercialization, starting with my first successful BLA and PAI over 25 years ago.

I’ve coordinated PAI readiness projects and served as the “CMC point person” during countless inspections by regulatory authorities from all over the world. I’ve learned how to plan and prioritize PAI readiness efforts, design (and sometimes present) the opening presentations, race to write up clarifications and corrections for issues raised during the inspection and develop appropriate responses to the final inspectional observations. I also have extensive experience in compliance remediation projects.

Along the way, I’ve written almost every regulatory CMC document there is to write (with lots of help from some great constructive critics!). I’ve coordinated the CMC efforts for INDs, BLAs, meeting packages, and responses to regulatory comments and questions. I’ve written SOPs, batch records, investigations and change control documents.

I’ve learned to quickly generate clear, accurate text that’s consistent with the overall regulatory message. In short, if you need help getting your firm on the road to regulatory readiness or writing up your “CMC story” for anything from an IND to a warning letter response, please give me a call.

I’d be happy to talk to you about your project and help out however I can.
— Maria McGarry