- A doctorate in Pharmaceutical Sciences having more than 32 years of Industrial Experience in the field of Pharmaceutical Research & Global Regulatory Affairs. Worked extensively in the field of Global Regulatory Submissions for the regions like USA, EU, Canada, Australia and Emerging Markets like Brazil, CIS & South Africa. Knowledgeable in Global Drug Development for Highly Regulated Markets like USA & Europe. The regulatory submissions include IND, ANDA, ANDS, MAA, DMF and CEP.
- Expertise in the development & execution of regulatory strategies for solid-orals, parenteral and ophthalmic formulations. The parenteral formulations also include oncological drug products too.
- Visited several countries including USA, UK, Germany, Sweden, Denmark, Netherlands, France, Spain, Italy, Canada, Australia & South Africa for attending a number of Scientific Advice Meetings with various regulatory agencies like USFDA, MHRA, BfArM, MPA, MEB, HPB, TGA, EDQM etc.
- Worked very closely with several overseas consultants like Washington Foods & Drugs, Kendle, AAC, INC Research, Canreg, Hewitt, PharSolutions, AET and Peter Monger associates.
- Spoken at numerous national seminars held by Indian Pharmaceutical Association and Indian universities.
- Published several scientific papers in various journals of national and international repute.
- Currently guiding 3 PhD scholars in the field of Pharmaceutics and Regulatory Affairs.
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