Advisor @ Global Institute of Regulatory Affairs (January 2013 - December 2013)
R and D Manager @ Enzochem Lab Pvt Ltd (January 1981 - December 1984)
Production Executive @ Haffkine Biopharmaceutical Corporation,Mumbai (India) (January 1977 - December 1978)
Rajkumar Gupta Education
Haffkine Institute, Mumbai, India
M.Pharm (Tech) (Pharmaceuticals)
1975-1977
Pr KMK College of Pharmacy
Bachelor in Pharmacy (Pharmaceuticals)
1972-1975
Rajkumar Gupta Skills
Filing US DMF for Cartons and corrugated boxes with US FDA for the possible exports
Government
Regulatory Submissions
eCTD
DMF
Training
Standard Operating Procedure (SOP)
Licensing
US DMF for Packaging Materials
US DMF for Excipients
CEP(Ph Eur) for API & Excipients
Health Canada DMF
EDMF for new API
US DMF for API & Intermediates
Dermatology
Operations Management
Software Documentation
Market Development
GMP
Toxicology
Sales
Regulatory Affairs
Pharmaceutical Industry
Validation
FDA
Sop
Formulation
Regulatory Requirements
Clinical Trials
ANDA
CTD
Pharmacovigilance
Chemistry
Pharmaceutics
Change Control
MHRA
Quality System
Cleaning Validation
Quality Auditing
ISO 13485
Quality by Design
Quality Control
Product Development
Technology Transfer
Biotechnology
V&V
Analytical Chemistry
Generic Programming
R&D
Lifesciences
Biopharmaceuticals
Drug Discovery
CAPA
Drug Development
Clinical Development
GCP
CRO
Vaccines
Dissolution
Medical Writing
CMC
Distribution
Marketing
Manufacturing
Storage
Standard Operating Procedure
Us DMF for Api and Intermediates
Cep for Api and Excipients
Rajkumar Gupta Summary
Rajkumar Gupta, based in Pune, MH, IN, is currently a Principal CEO at FDApals. Rajkumar Gupta brings experience from previous roles at Perfect Pharmaceutical Consultant Pvt Limited, Perfect Pharmaceutical Consultants Pvt Limited and Global Institute of Regulatory Affairs. Rajkumar Gupta holds a 1975 - 1977 M.Pharm (Tech) in Pharmaceuticals @ Haffkine Institute, Mumbai, India. With a robust skill set that includes Filing US DMF for Cartons and corrugated boxes with US FDA for the possible exports, Government, Regulatory Submissions, eCTD, DMF and more. Rajkumar Gupta has 1 emails and 1 mobile phone numbers on RocketReach.
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