Dhaval Gaglani
Branch Chief at FDA/CDER/OPQ/OLDP
- Role
- Branch Chief at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
Experience
Branch Chief
Jan 2015 — Present · Washington, DC, US
Branch Chief in CDER\'s Office of Pharmaceutical Quality (OPQ), Office of Lifecycle Drug Products (OLDP), Division of Immediate and Modified Release Products. Responsibilities include supervision of CMC assessors responsible for drug product quality assessment of Abbreviated New Drug Applications (ANDAs) for Immediate (IR) and Modified Release (MR) solid oral dosage forms, and Inhalation dosage form including Metered Inhalers (MDI) and Dry Powder Inhalers (DPI). Also responsible for evaluating drug product quality aspects and responding to Controlled Correspondence (CC) and Pre-ANDA meetings for Generic Drug-Device Combination Products.
Education
College of Pharmacy
Bachelor of Pharmacy (B.Pharm.)
1991 — 1994
Long Island University
Doctor of Philosophy (Ph.D.)
2002
Long Island University
Master of Science (MS)-Pharmaceutics
1996 — 1999
Skills
- Formulation
- Technology Transfer
- Quality by Design
- Regulatory Affairs
- Product Development
- Pharmaceutical Industry
- Gmp
- Sop
- Validation
- Drug Development
- Pharmaceutics
- Cmc
- Biotechnology
- Regulatory Submissions
- Cmc Regulatory Affairs
- Prod
- Pharm
- Drug Delivery
- R&D
- Glp
- Hplc
- Standard Operating Procedure (Sop)
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