Nita U. Patel

Biography

 Dr. Nita Patel is responsible for CMC and global pharmaceutical regulatory issues. Dr. Patel has over 30 years of research and professional experience in R&D and pharmaceutical development. She has extensive hands-on global regulatory and quality experience with INDs/CTAs, License Applications (BLA/NDAs), life cycle management, regulatory agency meetings and inspections, change control, compliance (GLPs, GCPs, GMPs), and advertising and promotional regulatory management. Dr. Patel has in-depth knowledge of product development, project management, partnering, due diligence (product and company), auditing (GMP, GLP, GCP), and risk management company strategies. Prior to joining The Weinberg Group, Dr. Patel has held multiple senior level executive positions including Senior Vice President of Operations at Artisan Pharma, Vice President of Regulatory Affairs and CQA at GenVec, and Project Director of Regulatory Affairs at MedImmune. Dr. Patel holds a Bachelor of Science in Biochemistry from Queen Elizabeth College, London and a Ph.D. in Molecular Biology and Yeast Genetics from University College, London. She is currently member of RAPs, PDA and serves on the board of Biosciences; Health Sciences and Medicines Cluster Advisory Board (CAB) at Montgomery College, Maryland. Dr. Patel is passionate about gardening and volunteering her time to children in need as a Court Appointed Special Advocate (CASA) for children representative.

Research Interest

      Clinical Pharamcology ,Medical Microbiology ,Immunology,Biotechnology