Introduction to the Due Diligence Process, Second Edition
Table of Contents
Chapter 1: Transaction Types and Gauging the Extent of Due Diligence
Chapter 2: Forming Due Diligence Teams
Chapter 3: Initial Interactions with the Target (Requesting Materials, Teleconferences and the Data Room)
Chapter 4: The Target’s Role in Due Diligence
Chapter 5: Role of the Regulatory Professional or Regulatory Legal Counsel in Due Diligence
Chapter 6: Regulatory Diligence Review
Chapter 7: Supplemental Requests and Diligence Calls
Chapter 8: Chemistry, Manufacturing and Controls and Supply Chain Diligence
Chapter 9: Nonclinical and Clinical Expert Due Diligence Roles
Chapter 10: Other Due Diligence Roles
Chapter 11: Creating and Negotiating Milestones
Chapter 12: Outputs of Due Diligence and the Final Diligence Report
Joanne S. Hawana, MS, JD, Benjamin M. Zegarelli, MS, JD, and Elizabeth K. Conti, JD, editors
About the Book
Available formats: print and e-book
Written by four legal regulatory experts, readers will benefit from this high-level guide through the due diligence process from a regulatory affairs perspective intended to help the regulatory team consider the key issues and ask the right questions during the process to gain helpful information about the target. Introduction to the Due Diligence Process, Second Edition will help the target’s regulatory team understand its role in the diligence and prepare for requests from the buyer’s team.
Updated 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, this second edition will afford you new 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.
Who will benefit from this book?
The book primarily targets regulatory affairs professionals who are new to the due diligence process and more experienced regulatory affairs professionals who may need a refresher on the various roles and responsibilities in a due diligence. This book also would be helpful to company executives running or overseeing the diligence process by providing a comprehensive description of the regulatory issues that should be considered. It also could be useful for attorneys who are either new to the regulatory side of due diligence or who want to gain a deeper understanding of the regulatory considerations of a life sciences transaction.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2020. Paperback. 143 pages. ISBN (print): 978-1-947493-45-2. ISBN (digital): 978-1-947493-46-9.
