Introduction

Emergent clinical affairs situation related to changing regulatory environment and discovery of potential compliance issues.

Aim

To understand the regulatory requirement, the product in question, and how to safely navigate and comply to the change in authority.

Method

This is a common client request. It requires cross-sectional teamwork starting with high-level analysis of the operating constraints and the challenge as it relates to the client’s product. The regulatory framework then needs to be understood together with how in the best interests of patients such regulation can be interpreted. In many regards this is a complex analysis integrating scientific literature and regulatory demands whilst steered with clinical relevance and pragmatism.

Conclusion

The report passed both in-house compliance and thereafter the examination of external auditing authorities. As a minimally significant outcome, it saved the client time. At its most impactful, it highlighted the benefits of that particular product, kept it available to the market, maintaining its market share and accordingly a crucial amount of revenue for the client.