
Brahma Singh
Sr. Director, Formulation Development @ Acadia Pharmaceuticals
About
An innovative R&D leader with ~25 years of extensive experience in pharmaceutical development for NCEs (19 years) and generic drug products (4 years), and ~2 years in commercial (solids) manufacturing and packaging. Industry experience includes small, mid-size and large pharmaceutical companies and covers CMC leadership, managing outsourcing activities at global CRO sites, and staff management with increasing responsibilities. Core expertise in oral solids (plus with few years in sterile powders for infusion) covering entire spectrum of early and late stage CMC development and regulatory submissions. Successful track record of product development and CMC leadership leading to regulatory approval and launch of four NDAs (Ceftaroline fosamil-Teflaro®, Cariprazine-Vraylar®, Nebivolol/Valsartan-Byvalsan®, and Ceftazidime/Avibactam-Avycaz®), >20INDs/IMPDs, and few ANDA filings for FTF (first to file) and FTM (first to market) opportunities.
United States
Syosset
Pharmaceuticals
Drug Delivery, Drug Development, Formulation, Pharmaceutics, Technology Transfer, Pharmaceutical Research, IND, GMP, Pharmaceutical Industry, Clinical Development, Regulatory Affairs, CMC, Regulatory Submissions, R&D, Pharmacokinetics, GLP, Product Development, Abbreviated New Drug Application (ANDA), New Drug Application (NDA)
Experience

Independent CMC Consultant
N/A
Worked directly with companies and as a per diem consultant for Lachman consultants.
Education
Brahma Singh's Contact Information
Phone
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