Bentley Biomedical Consulting
Bentley Biomedical Consulting specializes in biomedical regulatory consulting for U.S. and global markets, providing timely regulatory results to enable sales of drugs and devices into markets including the U.S., Australia, Brazil, Canada, China, the European Union, and India. They have a proven track record with drug companies seeking innovative approval paths, including 505(b)(2). The company is led by Shep Bentley, a regulatory affairs professional with a diverse background and military service, dedicated to advancing the life sciences.
Industries
Nr. of Employees
small (1-50)
Bentley Biomedical Consulting
28241 Crown Valley Parkway, Suite 510(k), Laguna Niguel, CA 92677
Services
Consulting for preparation and submission of regulatory filings to obtain market authorization for medical devices in the U.S. and international jurisdictions.
Regulatory strategy and submission support for drug approval pathways including 505(b)(2) and ANDA applications.
Regulatory planning and submission support for combination products and assistance with regulatory authorizations across multiple international markets.
Consulting for preparation and submission of regulatory filings to obtain market authorization for medical devices in the U.S. and international jurisdictions.
Regulatory strategy and submission support for drug approval pathways including 505(b)(2) and ANDA applications.
Regulatory planning and submission support for combination products and assistance with regulatory authorizations across multiple international markets.
Expertise Areas
- Regulatory compliance and submissions
- Drug approval pathways (505(b)(2), ANDA)
- Combination product regulatory strategy
- Medical device regulatory strategy
Key Technologies
- Regulatory dossier preparation
- Regulatory pathway analysis
- Global regulatory intelligence
- Regulatory strategy for combination products