With the increasing difficulties in internally-generated product development, drug, biologics, and device firms of all sizes are looking to acquisitions to augment product lines. Whether in the form of single products or whole companies, transactions can make or break the future of a company. However, often lost in the frenzy of a deal involving highly-regulated biomedical companies or products is the critical need to ensure that regulatory, clinical, and quality considerations do not undermine the value or viability of an investment. This webinar will focus on the key regulatory, quality, and clinical issues, including data integrity failings, that must be reviewed when purchasing an FDA-regulated product or company and how to adequately address those concerns in the due diligence phase. The presentation will highlight issues that can undermine a deal altogether or create burdens in the integration phase and how to ensure these issues are properly addressed in advance. The panel will address a “checklist” of items acquiring companies should consider as part of their due diligence, followed by a discussion of specific techniques these companies can use to determine whether due diligence issues exist.

Ann Begley, Partner, Morgan, Lewis & Bockius LLP
Jack Garvey, Chief Executive Officer, Compliance Architects LLC
Michael Swit, Managing Principal, Law Offices of Michael A. Swit