Kinexum provides ‘red team’ reviews and assessments at key points in development for 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.
Kinexum takes a team-of-experts approach, bringing together professionals in all disciplines required for a project to provide optimal review and advice. We do not view ourselves as outside consultants but treat your project as if it were our own. Our collective expertise is applied to determine what we ourselves would do under the circumstances (although, of course, you make the final decisions).
Our Approach to Regulatory Due Diligence
At Kinexum, we employ a systematic approach to regulatory due diligence designed to uncover critical insights and mitigate risks effectively. Our process typically includes:
- Identification of Relevant Concerns: In early meetings, Kinexum consultants will work with you to identify the the specific needs and concerns associated with the project, allowing you to reduce expenditure and shorten timelines.
- Regulatory Review at the Relevant Depth: Ideally, we thoroughly assess your regulatory dossier, including submissions, correspondence with the FDA, and compliance records. However, we will consider the level of review and analysis that is ‘fit for purpose,’ accounting for any constraints on time and/or expense. When necessary, we can take a business-like ‘80-20 rule’ approach to the level of review and analysis.
- Risk Assessment and Mitigation: Where we identify regulatory, clinical, CMC, non-clinical, and even commercial issues, we evaluate the level of risk and recommend steps and strategies to mitigate it.
- Evaluation of Quality Systems: We assess the robustness of your quality management systems (QMS) and documentation practices to ensure that they meet FDA standards. We do this by reviewing SOPs, validation protocols, and other quality-related documents. This can be at the level of an audit or a more informal review.
- Due Diligence Reporting: Upon completion of our assessment, we provide you with a draft report outlining our findings, recommendations, and action plans for your team to discuss and execute. As requested, we make ourselves available to answer questions and speak with your team, management and/or board, investors, contract counterparties, and other stakeholders.
