The launch of a product is one of the most critical moments in its life-cycle. The product trajectory is firm within the first six months for 85% of pharmaceutical launch. Understand the end goal and product-specific requirements. Rely on science and experience as it is a strong scientific rationale which wins more often than not. Lastly, keep in mind that strong relationships and appropriate interactions with the FDA can reduce development timelines.
Michael Day, Phd Director Regulatory Science & Co-Head Complexe Biologics
As a Director Regulatory Science and Co-Head Complex Biologics at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies.