Case 2

The Client

A start up pharmaceutical company, preparing to submit its first IND for innovative medicines designed to help patients with neurodevelopmental disorders.

The Situation

The client did not have the Regulatory expertise necessary to complete the submission properly and quickly. With a full-time staff of just four, they recognized the need for outside help.

They also understood that an improperly submitted IND could result in a refusal to file, something which would require redoing the submission and considerably more cost over the long term.

Our Work

Working alongside the client team, we managed the timelines and submissions for all aspects of the IND process.

As work progressed, and seeing the benefits of MLC’s involvement, our client brought in a total of four MLC expert consultants over the next six years, in support of Regulatory (including Operations) Intellectual Property and Pharmacovigilance/Drug Safety needs.

The End Result

Over a six year period, we completed and provided over 100 serial submissions to the FDA for review on behalf of our client.

Two INDs for two different products were successfully filed and given the green light for Clinical trial initiation. The programs have advanced into Phase 2 and Phase 3 Clinical trials.