Our Partners
Biomedical Regulatory Consulting for U.S. and World Markets
Shepard G. Bentley, RAC
Medical Devices for U.S. and Global Market
Shep Bentley, QuadKor’s regulatory affairs expert, provides timely regulatory results to enable sales of drugs and all classes of medical devices into the U.S. and global markets, to include Australia, Brazil, Canada, China, the European Union and India.
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.
Services
- Device submissions to FDA, Global Markets
- 505(b)(2) Drug Approvals, ANDAs and Combination Product approvals
Certifications
- Regulatory Affairs Certification – United States Regulatory Affairs Certification
- The Organisation Of Professional Regulatory Affairs (TOPRA) (United Kingdom)
- American Society for Quality (ASQ) Internal Auditor (USA)
Publications
- Finding a Balance in the Assessment of Risk,
Genetic Engineering and Biotechnology News, Mar 1, 2006.
An explanation of a position taken against an imbalance in the assessment of risk, particularly by overly cautious industry in front of the FDA, and the adverse impact on public health of the precautionary principle as applied to novel biomedical technologies
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)