Why Regulatory Due Diligence Matters
Effectively navigating the FDA regulatory framework requires an unusual combination of highly technical expertise, a “big picture’ perspective of policy and regulations borne of multiple interactions with and/or experience within the agency, a creative, science-and-policy-based ability to make a case to the agency, and a strategic, client-centric understanding of corporate objectives and constraints.
Regulatory due diligence, both on the “sell-side” and “buy-side,” certainly applies in the case of companies engaged in M&A and fundraising, but also in product, portfolio and corporate development planning and periodic monitoring and assessment. Kinexum provides both ‘turnkey’ strategic and operational regulatory services for emerging companies with limited internal regulatory functions, and ‘red team’ reviews and preparation for interactions with the agency for clients with an experienced internal team, but who want an independent review, risk mitigation strategies and identification of opportunities to increase value and decrease time and expense.
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 the Relevant Problem to be Solved: Because our consultants are highly experienced life science product development experts, early consultations will include joint definition of the right questions to enable the Sponsor to use tractable answers that make a directional difference in strategy, expenditures and timelines.
- Regulatory Review at the Relevant Depth: Ideally, we will conduct a thorough assessment of your regulatory dossier, including submissions, correspondence with the FDA, and compliance records. However, we also recognize the right level of review and analysis that is ‘fit for purpose,’ in light of any applicable constraints on time and/or expense. In consultation with the client, we have the confidence to bring a business-like ‘80-20 rule’ approach to the level of review and analysis, when necessary.
- Tractable Risk Assessment and Mitigation: Where we identify regulatory, clinical, CMC, non-clinical, and even commercial risks and issues, we convey our judgments about levels of risk and recommend risk mitigation steps and strategies, while also looking for opportunities for enhancing value and reducing time and expense.
- Evaluation of Quality Systems: As requested, we assess the robustness of your quality management systems (QMS) and documentation practices to ensure they meet FDA standards. This includes reviewing SOPs, validation protocols, and other quality-related documents. This can be at the level of an audit, or a more informal review.
- Client-centricity: Kinexum brings a team-of-experts approach, like a law firm that draws on corporate, tax, securities, commercial, antitrust, etc. experts, as needed, to provide optimal review and advice…but not so much as just outside consultants, but as if our client’s project was our own project, on which we are spending our own money; so our collective expertise is applied to recommend what we ourselves would do under the circumstances (though of course the client makes the final decisions, informed by our analysis and recommendations).
- Due Diligence Reporting: Upon completion of our assessment, our typical approach is to provide you with a draft report outlining our findings, recommendations, and action plans, for discussion with your team and finalization. As requested, we make ourselves available to answer questions and discussions with your team, your management and/or board, investors, contract counterparties and other stakeholders.
Rescue Services for Regulatory Compliance
In instances where compliance challenges have arisen or regulatory issues require immediate attention, our rescue and salvage services offer swift and effective solutions. We specialize in identifying root causes of non-compliance, developing corrective action plans, and guiding you through the process of remediation.
Whether you require assistance with FDA correspondence, remediation of inspection findings, or implementation of corrective and preventive actions (CAPAs), our team is committed to providing responsive support to help you regain compliance and maintain operational continuity.
Why Choose Kinexum?
- Expertise, Experience and Judgment: Our team consists of seasoned regulatory consultants with extensive knowledge of FDA regulations and industry best practices.
- Hybrid ‘Algorithmified’ and Customized Solutions: We understand that each client has unique needs and challenges. And we understand that most problems are not new, and could benefit from algorithms derived from multiple engagements. We revel in striking the balance, to optimize effective yet efficient outcomes.
- Curiosity, Creativity and Efficacy. We are life science product development ‘geeks.’ We are experts and perennial students of our art and craft of life science product development and problem solving.
- Ownership: We are committed to delivering high-quality services that would meet or exceed our own rigorous standards, if we ourselves were the client.
