Dr Vinay Nayak , a pharmaceutical professional with technical background has worked with Organisations such as Cipla, Lupin, Watson, Alembic & Emcure pharmaceuticals for past 32 years.
I have specialised in the areas of Manufacturing, Quality, R&D , compliance and Regulatory Affairs both for API and formulation manufacturing.
My first job was at cipla for 20 years in which i was responsible for setting up corporate Quality, Regulatory and R&D formulations functions. Cipla faced the first USFDA inspection as early 1984 which was considered as early entry to US market with DMF filings of High barrier APIs
I have successfully handled about 50 USFDA and 30 other regulatory inspections with g...