Life sciences transactions involve a key component not found in other commercial transactions — the product or company of interest is regulated by the FDA, and regulatory issues therefore must be carefully considered. Greenleaf applies vast FDA institutional knowledge to equip investors with the thorough and focused due diligence needed to ensure that decisions and transactions reflect regulatory risk.
Advisory Services Team
Greenleaf’s team of advisors offers a rare blend of perspectives developed as leaders in both the private and public sectors. Our experience enables us to deliver valuable insight on the broad life sciences industry and the FDA’s current thinking in multiple areas, throughout the product lifecycle.
Brian CorriganExecutive Vice President, Regulatory Policy
John TaylorPresident and Principal, Compliance and Regulatory Affairs
Robert J. Meyer, M.D.Principal, Drug and Biological Products
John K. Jenkins, M.D.Principal, Drug and Biological Products
Karen Midthun, M.D.Principal, Drug and Biological Products
Daniel Schultz, M.D., F.A.C.S.Principal, Medical Devices and Combination Products
Maura M. Norden, J.D.Executive Vice President, Medical Devices and Combination Products and General Counsel
David ElderPrincipal, Regulatory Compliance
Cynthia SchnedarPrincipal, Regulatory Compliance
Kalah Auchincloss, J.D., M.P.H.Executive Vice President, Regulatory Compliance and Deputy General Counsel
Mark KramerExecutive Vice President, Medical Devices and Combination Products
Our Advisory Services
Regulatory Risk Assessments
The firm’s multidisciplinary team uses its deep regulatory expertise to perform risk assessments that take into account business objectives, transaction timelines, and the industry landscape. Greenleaf’s comprehensive due diligence services evaluate a company’s pipeline, or a specific asset, in the following areas:
Regulatory Landscape Series
Our Regulatory Landscape Series offers insights from Greenleaf professionals on emerging regulatory matters.
Stay tuned for future installments in the Regulatory Landscape Series. To join Greenleaf’s advisory services e-newsletter, please contact Brian Corrigan at Brian.Corrigan@greenleafhealth.com or provide your contact information via the below form:
Conducting Due Diligence to Guide a Corporate Acquisition Decision
Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …