Biomedical Regulatory Consulting for U.S. and World Markets
Shepard G. Bentley, RAC from Bentley Bio Med
Medical Devices for U.S. and Global Market
BBC provides timely regulatory results to enable sales of drugs and all classes of devices into the U.S. and global markets, to include Australia, Brazil, Canada, China, the European Union and India.
Shep Bentley is a regulatory affairs professional who leads a team with diverse talents, qualifications and cultural backgrounds to enable unconventional results at competitive rates.
A student of literature, law and medicine with a knack for languages and debating, he has a passion for championing new ideas and approaches to the age old problems of health care to regulators.
He and his team are resourceful, perpetually inquisitive and dissatisfied with the more burdensome approaches to portraying safety and effectiveness to the government. Their combined education spans the range of life sciences through the doctoral level. Shep retired from the reserve of the U.S. Marine Corps as a Lieutenant Colonel in 2005, after having served in Iraq. He is dedicated to the advancement of the life sciences.
- Device submissions to FDA, Global Markets
- 505(b)(2) Drug Approvals, ANDAs and Combination Product approvals
Certifications and Affiliations
- American Academy of Dermatology (AAD)
- American Association for Respiratory Care (AARC)
- American Burn Association (ABA)
- American Cancer Society (ACS)
- American Heart Association (AHA)
- American Lung Association (ALA)
- American Neurology Association (ANA)
- Association for the Advancement of Medical Instrumentation (AAMI)
- American Society for Quality (ASQ), Biomedical Section
- College of American Pathologists (CAP)
- Drug Information Association (DIA)
- International Society for Quality of Life Research (ISOQOL)
- Parenteral Drug Association (PDA)
- Regulatory Affairs Professional Society (RAPS)
- The Organization of Professionals in Regulatory Affairs (TOPRA)
Address: 9655 Granite Ridge Dr #200
San Diego, CA 92123
QuadKor Business Software Solutions
9655 Granite Ridge Dr #200, San Diego, CA 92123, USA