• About 17 years of rich experience in formulation development & research centers, developing drug product in varied renowned, reputed, leading pharmaceutical organizations catering to regulated (US, Canada, EU, AUS, NZ, CH, ZA, BR, Japan and emerging) markets. Significant experience in formulation development, scale ups and related issues, through understanding of bioequivalence, outstanding track record of bio success, strong background of handing more than 150 products deficiencies addressing to previously filled drug products for US–FDA, Health Canada, MHRA, TGA, MCC, PMDA etc., co-ordination with all stake holders for smooth timely filling and related support during compliance audit by different regulatory body (like US-FDA, Health Canada, MHRA, PMDA etc) at manufacturing location and R&D.• Can set up R&D infrastructure in startups in minimal time and help organizations in building a good portfolio. Combine knowledge of formulation, analytical, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required regulatory expectations. • Support senior management in selection of product portfolio, planning, evaluation and finalization of regulatory strategy.

Worked about 9 years in R&D of Mylan Laboratories Ltd, Hyderabad. Having the expertise of SCOT, Controlled release tablets, bi-layer, tri-layer, tablet in tablet, Hotmelt and Nanocrystal technology. Filled 15 FTF products and about 100 dossier across the geography.

• Scientific expertise for developing Controlled Release and Immediate Release Solid oral dosage form for Global market like US, Canada, Europe, Australia, Newzeland, Japan. Like – Pellets, Spheroids, Minitablets, Orally Disintegrating Tablets, Dispersible tablets, Granules for Suspension, MUPS tablets and Matrix Tablets.• Scientific expertise to develop stable product containing entire range of PPI’s as pellets or beadlets filled into capsules, MUPS tablets and granules for oral suspension