Regulatory Due Diligence

Kinexum provides ‘red team’ assessments for both emerging companies with limited internal regulatory resources and experienced clients who want an independent review. Our consultants provide risk mitigation strategies and identify opportunities to increase value and decrease time and expense.

We can work at the level of an audit or a more informal review. Ideally, we will thoroughly assess your entire regulatory dossier. However, we adapt to the level of review that is best for you, taking into account any constraints on time or expense.

Our typical approach:

In early meetings, our consultants work with you to identify your specific needs and constraints within your timeline and budget.
Our experts analyze your previous submissions, correspondence with regulatory agencies, and compliance records. We look at your quality management systems (QMS) and documentation practices to ensure that they meet regulatory standards.
Where we identify regulatory, clinical, CMC, nonclinical, and commercial issues, we evaluate the level of risk and outline mitigation strategies.
Upon completion of our assessment, we provide you with a draft report outlining our findings and recommendations. This report can be updated if requested.
As needed, we make ourselves available to answer questions and speak with your team, management, board, investors, contract counterparties, and other stakeholders.