Regulatory Approval

Our Client: Small pharmaceutical firm seeking regulatory assistance.

The Client had just acquired a drug candidate with two complete Phase 3 studies and needed to establish positive interactions with the FDA but didn't have the staff to accomplish these goals.

Safis provided the people and the programs to enable the Client to accomplish its goals. Safis assisted with data preparation and assembly, worked closely with CRO's and manufacturing contractors to assimilate repaired information for submission and prepared documents for the NDA. Safis also prepared and led FDA interactions.

As the Client added full time internal employees, Safis helped in the identification and assimilation process such that the Client could be self-sufficient in the future.

The Client plans to submit its NDA in Q1 2008, an EMEA submission by summer 2008 and have re-initiated its global clinical development program.