IND and NDA Submission Strategy
In addition to writing components of INDs and NDAs, our regulatory affairs consultants can also provide IND and NDA submission consulting and management.
For an IND, this can involve such activities as developing a forward-looking plan to propose to the Agency, devising a strategy for presenting existing nonclinical and clinical data, determining the extent of literature review needed, and advising on when and how to submit your IND.
For an NDA this can involve such activities as developing and maintaining detailed timelines, determining how best to pool and present data from the completed clinical trials, and coordinating the efforts of personnel from multiple functional areas (clinical, nonclinical, CMC, stats, etc).
We have also assisted in preparation of and participated in numerous preIND and preNDA meetings across multiple reviewing divisions.