Mintz Member Joanne Hawana and Associates Benjamin Zegarelli and Elizabeth Conti co-authored the second edition of “Introduction to the Due Diligence Process,” a high-level guide through the transactional due diligence process from a regulatory affairs perspective, recently published by the Regulatory Affairs Professionals Society (RAPS). The book also includes an introductory chapter written by Mintz corporate Associate Scott Dunberg.

The second edition of RAPS’ “Introduction to the Due Diligence Process” is intended to help regulatory affairs professionals, company executives, attorneys, and others to learn the ins and outs of the due diligence process, the roles and responsibilities regulatory professionals play, and essentials for executing successful due diligence in life sciences transactions.

Updated from its first iteration to incorporate modern elements of the due diligence process, such as changing the focus from on-site document review to the use of virtual data rooms, the second edition offers perspectives on the role of regulatory counsel as part of the due diligence process and descriptions of the diligence responsibilities of the seller’s team to supplement the existing information on the buyer’s responsibilities.

Specifically, the book provides expertise on the following:

• Understanding the flow of the due diligence process;
• How to prepare for a diligence process and creating questions and document requests that will yield crucial information about the target;
• Understanding the various due diligence roles and whom to contact about various issues; and
• How to negotiate regulatory milestones for the transaction.

Ms. Hawana counsels global clients on regulatory and distribution-related considerations to bringing a new U.S. Food and Drug Administration (FDA)-regulated product to market. She also advises clients on the business impact of new U.S. federal and state actions that affect those regulated products, such as drugs, foods, and medical devices, among others.

Mr. Zegarelli counsels clients on compliance and regulatory issues, with a focus on FDA regulations. He advises clients in the pharmaceutical, medical device, and biotech industries, and provides counsel on pre- and post-market regulatory strategy, quality system compliance, and clinical trial agreement negotiations.

Ms. Conti focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceutical, medical device, dietary supplement, cosmetics, and food industries, as well as pharmacies and distributors.

Mr. Dunberg represents public and private companies in a broad range of transactions and corporate matters. His practice focuses primarily on mergers and acquisitions, venture capital financings, capital markets transactions, securities law compliance and general corporate representation. 

Notably, this is the second consecutive year that Mintz health law attorneys have authored a RAPS publication. In 2019, Ms. Hawana and Mr. Zegarelli co-authored the book entitled “Promotion of FDA-Regulated Medical Products,” which serves as a thorough and practical guide for professionals involved in developing promotional and advertising plans for new prescription medical products.

Founded in 1976 and headquartered outside of Washington, D.C., RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products. The second edition of “Introduction to the Due Diligence Process” is available to purchase in paperback and e-book format. To read a sample chapter, please click here.