Dr. Rastogi brings over 25 years of extensive experience in the pharmaceutical industry, specializing in the development of a wide range of conventional and complex dosage forms. With a strong scientific background and strategic expertise, Dr. Rastogi has led various aspects and stages of product development, demonstrating proficiency in pre-formulation, materials characterization, analytical development, formulation and process development, quality by design, stability studies, manufacture of cGMP clinical supplies, scale-up, technology transfer, and commercial launch of dosage forms.
Throughout his career, Dr. Rastogi has successfully managed over 100 internal and external development projects, including several challenging high-value blockbuster products such as Namanda XR and generic Concerta, Adderall XR. His experience extends to writing and reviewing CMC sections of regulatory submissions, including FDA meeting requests, briefing packages, INDs, ANDAs, and NDAs. As a senior member of R&D teams, he has contributed to reviewing and approving various sections of regulatory documents, including CMC, non-clinical, and clinical sections.
Dr. Rastogi holds a strong educational background in Pharmaceutical Science, 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.
With his wealth of experience and expertise, Dr. Rastogi continues to make significant contributions to the pharmaceutical industry, driving innovation and advancing the development of novel drug delivery systems.