Understanding Multinational Regulatory Filings: New Chemical Entity

By Jim Springer, Steve Halpin, and Megan Kuikstra, Grace FCMS

Finding the right long-term CDMO partner for development and commercial launch of a new chemical entity (NCE) presents sponsors with a uniquely challenging scenario. First, “right” must be defined in quantifiable metrics, then the search begins for a CDMO exhibiting those qualities. The challenge is magnified when a multinational launch is planned.

For many sponsors, the search for a CDMO partner begins in earnest during phase two of clinical trials: the new chemical compound, chemical structure, or mechanism of action (MOA) is producing positive results, and the sponsor is actively evaluating the patient population and dose. They are trying to estimate volumes for launch and predict where growth might take the product in five or ten years.

To navigate these steps for commercial launch, particularly through parallel multinational filings, most sponsors seek a CDMO partner that offers clear, direct communication, proven compliance expertise in similar projects, and the infrastructure to quickly ramp up production in response to surges in demand or entry into new markets. Not every CDMO offers those skills and assets.