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.
BBC has a proven track record with numerous drug companies seeking innovative paths to approval, including the 505(b)(2).
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.