Beverly G. Lewis, RAC - Principal

• Regulatory Affairs Certified
• 30 years pharmaceutical experience
• Over 20 years experience in CMC Regualtory Affairs
• Successful preparation and/or review of:
• Original Investigational Applications
• Original Marketing Applications
• Amendments, Supplements and Variations for pending and approved dossiers
• Letter Responses
• Annual Reports
• Member: Regulatory Affairs Professional Society, Parenteral Drug Association, American Chemical Society, American Association of Pharmaceutical Scientists
• Instructor for Pharmaceutical Training Institute: "Complying with Chemistry, Manufacturing, and Controls (CMC) Requirements"
• Publications:
• Lewis, Beverly. 2002. "Outsourcing CMC Regulatory Affairs Services." Contract Pharma (Volume 4 Number 4): 72-84.
• Renn, Mike, Karen Hall, Dennie Harris, Beverly Lewis, and Adriawa Evans. 2000. "How Outsourcing Providers Can Meet Challenges and Opportunities." Pharmaceutical Technology Contract Services (August).
• Lewis, Beverly, Mike Renn, and Ken Manning. 2000. "CMC Section Development: An Integral Part of the Regulatory Process." Innovations in Pharmaceutical Technology (Volume 00 Issue 6):125-128.
• Presentations:
• "Differentiating CMC Requirements for Phases I through III," Chemistry Manufacturing and Controls, 2004 Conference sponsored by the Institute of International Research, July 2004
• "Analytical Methods Validation Through Drug Development, Registration, and Marketing," Chemistry, Manufacturing, and Controls Conference sponsored by Barnett International, January 2003.
• "Successful Contract CMC Dossier Preparation," Chemistry, Manufacturing, and Controls Conference sponsored by Barnett International, January 2001.