Shepard G. Bentley
2004 – Present: Bentley Biomedical Consulting, LLC. Laguna Niguel, California. Founded consultancy for device and drug regulatory strategies in U.S., EU, Canada, and Brazil. Guide risk management, regulatory and reimbursement strategies. Prepare 505(b)(2) submissions, engage FDA for pre-submission communications, and train staff for FDA interactions. Work with pharmaceutical firms in Asia (China, Malaysia and India) to achieve FDA regulatory approvals for generic drugs. Vice President of Regulatory Affairs at ACTUS Biotechnologies, Inc. for drug development and regulatory strategy for new drug forms on behalf of Convoy Therapeutics, Inc. and EnduRx Pharmaceuticals, Inc., both wholly owned subsidiaries. Develop clinical strategies and least burdensome approach to approvals. Work with foreign government ministries and other regulators. Help determine reimbursement for new products.
1984–2004: Hospital Corporation of America (Research Technician), Kendall-McGaw Labs (GMP Drug Production Management for non-parenteral and ethical drugs and drug substances), TOSHIBA America (Device Operations Management), Rising Star Contract Services, Inc. (Founder, CEO), Medical Quality Systems (Founder, Sole Proprietor), Volcano Corp. (Director of QA), Synergy Biomedical, LLC (CEO).
Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (U.S.) The Organisation Of Professional Regulatory Affairs (TOPRA) (United Kingdom) American Society for Quality (ASQ) Internal Auditor (USA).
Naval War College (United States Navy) Masters Program, Operational Planning Johannes Gutenberg-Universität (Germany) Advanced Studies, Philology The University of The South (USA) Baccalaureate, International Literature.