As pharmaceutical products have become more complex, many companies have become bogged down in accomplishing their primary mission of launching new products by complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to the patients.

The “messy, getting started” period in pre-product development can make many development teams and life science organizations uncomfortable – until you recognize “fuzzy” as less of a warning, and more of an invitation.

The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.