Challenge:
Our client was a US-based venture capital fund, with whom we have a long-standing retainer agreement to provide specialized due diligence support for their fund investment decisions. In this instance, the client required a regulatory affairs consultant with specific knowledge of FDA's requirements for registration data in atrial fibrillation. Our client was considering an investment in a European biotech company developing a novel arrythmia therapy in Europe, and wanted to understand how well the data from the planned set of clinical trials would enable regulatory submission the the US.
Solution:
Alacrita happened to have a regulatory affairs consultant who had previously worked for a US company which had brought an A-Fib drug to market. The consultant had managed the regulatory submission, and therefore brought precisely the knowledge and insight that our client was looking for. The consultant reviewed the European clinical plan, and company correspondence with the regulatory authorities, and reviewed drug labels for recently approved A-Fib products in US. The consultant also prepared a summary of how the cardio/renal division of the FDA thinks about the safety and efficacy of new oral afib anti-arrhythmics. Taking this feedback into account, our client proceeded with their investment.
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