Dr. Rastogi brings 25 years of extensive experience in the development of a variety of conventional and complex dosage forms including oral dosage forms, injectables, long-acting, amorphous solid dispersions, ophthalmic, topical, nano particulates, peptides, nasal sprays, and rectal gels. He has strong scientific and strategic expertise and has led various aspects and stages of product development including pre-formulation, materials characterization, analytical development, formulation and process development, quality by design, stability, manufacture of cGMP clinical supplies, scale-up, technology transfer and commercial launch of dosage forms. He has a proven track record of successfully managing over 100 internal and external development projects, including several challenging high-value blockbuster products (examples include Namanda XR and generic Concerta, Adderall XR).
He has significant experience in writing and reviewing CMC sections of regulatory
submissions including FDA meeting requests and briefing packages, INDs, ANDAs, and NDAs. As a senior member of the R&D teams, he has been involved in reviewing and approving various sections of these regulatory documents including CMC, non-clinical, and clinical sections. Dr. Rastogi has a strong educational background in Pharmaceutical Science from reputed schools with a Bachelor's degree from the Indian Institute of Technology-BHU, and a Ph.D. from the University of Minnesota. He has authored numerous patents and publications in drug delivery, pharmaceutical characterization, solid-state reactions and phase transitions, X-ray powder diffractometry, novel technology development, and protein stabilization.
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