Pharmaceutical & BioTech

A pharmaceutical company with a combined portfolio of medicinal products, medical devices and food supplements aiming at expanding its presence in various therapeutic areas.

• RPN conducted rigorous regulatory due diligence for M&A activities in the pharma sector, addressing high-risk challenges.
• Focused on a comprehensive compliance review of all documents related to the Marketing Authorization and to CMC aspects, comparing them with current manufacturing processes.
• Delivered an insightful due diligence report with significant findings and advice for future actions.

The client was involved in high-risk mergers and acquisitions within the pharmaceutical sector, requiring detailed due diligence to assess regulatory compliance of various product categories. This was crucial to identify risks and guide further action.

RPN dedicated a multi-disciplinary team to conduct a detailed regulatory due diligence process, tailored to the specifics of the target portfolio. The team reviewed critical aspects such as CMC documentation, non-clinical and clinical studies, post-approval commitments, and Sunset Clause issues. Utilizing a ‘data room’ for information access, RPN efficiently managed the process within a strict deadline.

RPN’s thorough due diligence resulted in a comprehensive report that highlighted all significant concerns and areas requiring further investigation. This report also included strategic advice for the client’s next steps, with discussions to review the findings. The client gained valuable insights to mitigate risks and make informed decisions in their M&A pursuits.