Voisin Consulting Life Sciences (VCLS), a global healthcare product development consultancy, and B&H Consulting Services, Inc. (B&H), an experienced regulatory firm helping pharma and biotech companies facilitate interactions with FDA and navigate the regulatory process, announced that they are joining forces. The transaction forms one of the largest independent consulting groups delivering high end regulatory services to support the interactions with the US Food and Drug Administration, the European Medicines Agency, and other global health authorities.

VCLS and B&H now have US offices in Cambridge, Somerville, and San Francisco in addition to Paris and Rennes, France; London, UK; Lausanne, Switzerland; Bangalore, India; and Singapore.

“The demand for US regulatory strategy and operations is very high, which made us accelerate the growth of our existing US teams,” says VCLS founder and CEO Emmanuelle M. Voisin, Ph.D.

“Helen Ribbans, founder and president of B&H, and her team possess outstanding expertise, credibility in the industry, and strategic vision that make them the ideal addition to the VCLS family.”

Founded in 1988 and based in Somerville, NJ, B&H provides strategic regulatory advice to pharma and biotech companies, and supports healthcare innovators in their interactions with US FDA. B&H also delivers in-depth chemistry, manufacturing and controls expertise, as well as strategic and operational support for all regulatory submissions including electronic publishing services.

“We are excited by the opportunity to expand the depth and breadth of services that we can offer to our clients as they seek to meet the regulatory requirements of the global healthcare market,” said Helen M. Ribbans, B&H founder and president.

“Joining forces with the VCLS group provides our clients with tremendous experience across all therapeutic areas, and the global footprint that they need to accelerate their results,” said Stephanie M. Pierson, who was named CEO of B&H as part of this transaction. Ms. Pierson previously was vice-president of B&H.

The combined team now includes more than 100 regulatory science professionals located across the United States, Europe, and South-East Asia. B&H will continue to operate under its current name, management team and structure, at its Somerville headquarters. Constantin Associates LLP, Kahn Partners LLP and Namaskar Corporate Finance acted as advisors to VCLS. Strategic Exit Advisors, Inc. and Norris McLaughlin & Marcus, P.A. acted as advisors to B&H.