Grey Crow Regulatory Consulting, L.L.C.

About Me: My name is Tom Crean, and I bring nearly 30 years of experience in developing drug biologics. I have worked with both start-ups and large companies, including Sanofi, Takeda, Novartis, Surface Oncology, and Intellia Therapeutics. View my personal LinkedIn profile here. Current Role: Consultant at Grey Crow Regulatory, specializing in Regulatory CMC services for the biotechnology and pharmaceutical industry. Core Interests: Cell and gene therapies Vaccines Monoclonal antibodies Therapeutic proteins for cancer Enzyme replacement therapies Services Offered: IND/CTA/DMF/BLA application support Submission project management CMC strategy and advice Product and submission life cycle support Briefing book authoring Contact Information: Reach out at info@greycrowregulatory.com or text 617-459-1730 to discuss how Grey Crow can assist with your project. Specialties: Cell therapy, Gene editing, CRISPR, Biologics, AAV, mRNA, IND, CTA, BLA, DMF, Device, CMC Development Strategy, Submission project management, Regulatory strategy, Product life cycle, Post Approval supplements, CBE30, PAS, IND annual reports, Post approval annual reports, Change control, Pharmaceutical manufacturing, Process development, Analytical development