Akums Drugs and Pharmaceuticals, Research and Development department
Banaras Hindu University, India
Overall, I am having nearby 10 years of experience in Pharmaceutical Industry after completing my Masters & Ph.D. degree in Pharmaceutical Sciences from Indian Institute of Technology (IIT) B.H.U., India with 16 research publication of my research work. All these years I have gained expertise in development of sterile and non-sterile products (Injectable, Solid oral, liquid, soft gel, Dry syrups, Ophthalmic, ointments etc). I also headed the Analytical research and development department and gained expertise in Method development, Validation, analytical testing and cGLP compliance etc. A very sound knowledge of Para IV filling and Product development for U.S. FDA, MHRA and CIS countries. Under my leadership, Company got DSIR approval of New R&D, set up by me. I also provided new technology platforms to the companies i.e. Aqueous based injections, conversion of suspension eye drops to solution form, Preservative free eye drops, Nano-particle based drug delivery systems, OROS based Drug delivery systems, Herbal eye drop, Sustained release suspension, quick and high penetrating topical delivery systems etc. Under my leadership companies got 8 patented technologies on different dosage forms. In addition to above achievements, I also have established R&D setup’s for two companies along with manpower and SOP’s control. I also have filed the dossier of 7 products for approval in CIS countries as per CTD/ ACTD formats. In all, I have developed 15 products for USFDA/ MHRA, 20 products for CIS countries and more than 70 products for domestic markets. Heading Research and Development Centre (NDDS) of Akums Drugs and Pharmaceuticals for last 3.9 years.
Formulation and development,NDDS (Nanoparticle, Nanoemulsion, Neosomes, OROS Drug Delivery system, Development of advanced injectable dosage form, Pharmacokinetics/ Pharmacodynamic, Drug Modeling, Invitro-Invivo correlation through mathematics modelling system, Analytical method screening and development of new drugs, Bioavailability and Bioequivalance, ICH/ FDA GUidlinace