Regulatory Due Diligence for FDA Regulated Companies

Presented by Darshan Kulkarni, PharmD, MS, Esq., this program is designed for professionals in the pharmaceutical, medical device, and broader FDA-regulated industries and includes not just regulatory professionals but also those in corporate law and mergers and acquisitions. It covers the importance of regulatory due diligence, the elements involved in the process, and key considerations for post-due diligence and post-transaction scenarios. The program emphasizes the legal, contractual, regulatory, and administrative aspects critical for effectively navigating the regulatory landscape.

This presentation is essential for professionals in the pharmaceutical and medical device industries, corporate law professionals, and individuals involved in mergers and acquisitions and offers valuable insights into the critical aspects of regulatory due diligence.

Learning Objectives:

1. Gain insights into why regulatory due diligence is essential for FDA-regulated companies, including its impact on legal compliance and business operations
2. Identify various elements of regulatory due diligence, such as contractual, regulatory, administrative, and legal considerations, and how they influence business decisions.
3. Explore Post Due Diligence Considerations and understand the steps and actions required after the due diligence process, including post-transaction integration and compliance strategies
4. Analyze Case Studies and review real-world examples and case studies that illustrate the application of regulatory due diligence principles in practical settings
5. Develop knowledge about developing and implementing an effective compliance program and managing risks associated with OIG, DOJ, and FDA requirements