Contract research and development and /or manufacturing of parenteral products: Steps for building a successful and mutually beneficial partnership
Neervalur V Raghavan
Rags Pharma Consulting, LLC, USA
: J Pharm Drug Deliv Res
Abstract
Work shop will cover discussion of the following areas from both Provider (R&D Laboratories and or contract manufacturing) and Customer (Pharma company) perspectives: (a) Selection of a mutually agreeable partner (b) Well defined goals (c) Regular team meetings utilizing project management tools (d) Selection of project and technical managers (e) Rapid resolution of technical, time and budget issues (f) Effective communication tools to meet goals within agreed upon time frame and budget g) Technology transfer (h) Risk based decision making (f) Assignment of a global leader from both partners for ensuring accountability to meet goals and objectives on time and budget.
Biography
Neervalur V Raghavan is an experienced leader of R&D organizations that have successfully developed novel formulations and implemented practical manufacturing solutions for drug entities that have poor solubility and limited shelf life. He has provided key leadership to drive strategic business initiatives, long term process optimization activities and the technical development of a scientific staff that is known throughout the industry. He is responsible for developing over 200 product presentations that include novel frozen drug formulations, inhalation therapy products, sterile, ready to use injectable antibiotic solutions and aseptic form fill seal injectable products. He has earned a PhD degree in Chemistry from University of Southern California, Los Angeles. After serving as a Postdoctoral fellow at Ohio State University, he joined University of Notre Dame focusing on radiation chemistry of low levels of aromatic aqueous solutions, utilizing HPLC and fast reaction kinetics. Then he joined Baxter Health Care Corporation and served there over thirty years, with increased responsibility, on sterile drug product development. He retired as VP of Pharmaceutical Product Development R&D. He had active membership with AAPS and ACS.
nvrags@gmail.com
