professional with 28 + years of rich diverse global experience in Formulation design, development and Manufacturing scale up of different dosage forms & delivery systems including liposomal products & Patents for the regulated markets. he is credited with the development & dossier submission of numerous ndas / andas. specialties: possess strong Formulation skills combined with sound business and scientific judgment in product positioning for commercial success in the international quality and regulatory arenas of the Pharmaceutical: Formulation / analytical / pkg. development, Technology transfer, Validation, stability studies & Patents activities of immediate/delayed / modified release products and injectables.
Head - R&D and Regulatory file preparation.
Since April 2005
·a new state of the art, custom design R&D of global repute(green field project) is created. -responsible for overall Formulation development and Clinical supplies manufacture for solid, liquid, semi-solid,injectables and medical nutritional products towards ind, anda and 505b(2) regulatory Applications. ·provided scientific Leadership & technical direction for Product Development projects and led multiple module groups of total 50+ scientific personnel. ·planed, organized, directed and monitored Product Development activities optimizing resources and expediting Clinical & registration accomplishment. managed department annual budget of $15+ million. ·responsible to introduce FDA’s 21st century initiatives (e.g. quality by design & pat). ·A new state of the art, custom design R&D of global repute(GREEN FIELD PROJECT) is created. -Responsible for overall formulation development and clinical supplies manufacture for solid, liquid, semi-solid,Injectables and medical nutritional products towards IND, ANDA and 505b(2) regulatory applications. ·Provided scientific leadership & technical direction for product development projects and led multiple module groups of total 50+ scientific personnel. ·Planed, organized, directed and monitored product development activities optimizing resources and expediting clinical & registration accomplishment. Managed department annual budget of $15+ million. ·Responsible to introduce FDA’s 21st Century initiatives (e.g. Quality by Design & PAT).
Dy. General Manager - R&DJanuary 2004 --- March 2005
·developed and commercialized several controlled release / sustained release/delayed release products i.e. floating Drug Delivery system (mosappiride citrate sr & pentoprazole enteric coated seeds.
Ph.D. in Pharmaceutics from Pune University,Pune,India in 2001
M.Pharm. in Pharmaceutics from Dr. H.S. Gour Universitty, Sagar, M.P. India in 1985
B.Pharm. in Pharmacy from Dr. H.S Gour University, Sagar,India in 1983