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
Company Details
- Founded
- -
- Address
- Cambridge, Ma 02139, Us
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- Cell Therapy, Gene Therapy, Autologous, Allogenic, iPSC, T Cell, Car T, Biologics, Vaccines, VLP, oligonucleotide, Monoclonal Antibody (mAB), CRISPR, Gene Editing, ADC, IND, CTA, IMPD, Briefing Book, Module 3, DMF, BLA, MAA, CMC strategy, Drug Development, Process Development, Manufacturing, mRNA, Lipid nano particle, AAV Vector, Validation, GMP, ATMP, FDA, EMA, ANSM, MHRA, CH, TGA, Change Control, CTD, Module 3, Quality, Change Control, Module 3 Templates, Authoring, Drug Regulatory Affairs, Novel Excipients, Adjuvants.
- HQ
- Cambridge, MA
Grey Crow Regulatory Consulting, L.l.c. Questions
Grey Crow Regulatory Consulting, L.L.C.'s LinkedIn profile is https://www.linkedin.com/company/grey-crow-regulatory
Grey Crow Regulatory Consulting, L.L.C.'s industry is
Pharmaceutical Manufacturing
Grey Crow Regulatory Consulting, L.L.C.'s top competitors are
Lessem Regulatory Consulting, Llc,
Elina Khachiyan Consulting, Llc,
Lenape Pharma Gmp Consulting, Llc,
Fd-Aid, Llc,
Compliance X Consulting,
Gmptraining.com, Inc.,
Destructdata, Inc.,
Cmc Tech, Llc,
The Sar Group, Llc,
Trubiotech.
Grey Crow Regulatory Consulting, L.L.C.'s categories are Pharmaceutical Manufacturing
Grey Crow Regulatory Consulting, L.L.C.'s founding year is 2023
