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Dr. Ajit Padgaonkar, M.B,B.S., MD.
Director |
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Dr. Nilesh Patel, , M.B,B.S., MD (Pharmacology)
Principal Investigator
Vast experience in conducting Clinical Trials / BABE studies for submission to various local & international regulatory authorities.
Experience in ANDA / Dossier submission to various regulatory authorities.
Mr. Nelson Varghese
Quality Assurance
Qualification: Masters in Chemistry
Responsible for Total Quality Management of the systems & procedures at DMRI.
Preparation / Review / Implementation of SOPs as per the DCGI / ICH – GCP / regulatory guidelines.
To ensure the implementations of the quality policies & continuous training / upgradation of the personnel’s / systems including safety & environmental protection.
Vast exposure to external regulatory / sponsor audits.
Dr. Ketan Nerurkar
Head – Bio-analytical
Qualification: Ph.D. (Analytical Chemistry)
Responsible for the complete functioning of the Bioanalytical laboratory at DMRI as per the SOPs / regulatory / cGLP guidelines.
Continuous monitoring of analytical method developments / validations / subject analysis as per the SOPs & GLP guidelines.
To ensure the authenticity / quality of data generated at DMRI bioanalytical laboratory
Dr. Tanay Padgaonkar, M.B,B.S.
Management Representative
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