Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
1: Transaction Types and Gauging the Extent of Due Diligence 2: Forming Due Diligence Teams 3: Initial Interactions with the Target (Requesting Materials, Teleconferences and the Data Room) 4: The Target’s Role in Due Diligence 5: Role of the Regulatory Professional or Regulatory Legal Counsel in Due Diligence 6: Regulatory Diligence Review 7: Supplemental Requests and Diligence Calls 8: Chemistry, Manufacturing and Controls and Supply Chain Diligence 9: Nonclinical and Clinical Expert Due Diligence Roles 10: Other Due Diligence Roles 11: Creating and Negotiating Milestones 12: Outputs of Due Diligence and the Final Diligence Report
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.