Over 11 + years of experience in pharmaceutical formulation and research development. Leading a group of scientists towards the development of solid oral dosage forms for regulated markets (USA, EU, Canada, Australia, Brazil and South Africa).Vast experience in development of stable, Non-infringing and bioequivalent formulations particularly immediate release, modified release solid oral dosage forms. Experience in design and development of mucoadhesive buccal tablets, extrusion/spheronization and pellets coating. Developed several ANDAs including a few First to file with paragraph IV. Developed several products for Europe market. Knowledge of ANDA, NCE-1 filings, 505(b)(2) filings with ...
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