Collaborating with you to navigate health authority interactions.
We have extensive experience in guiding development teams and investors from initial filing through regulatory approval.
Our regulatory support experience is multi-layered and extensive.
We'll make it easy. Our specific expertise includes:
- Regulatory pathway strategy and process for submission of INDs, NDAs, BLAs, and MAAs.
- Written and face-to-face communications with FDA & EMA.
- FDA meetings preparation for pre-IND, EOP2, pre-NDA, AdComs and “Clinical Path for Innovation meetings” (CPIM) and Voluntary Exploratory Data Submissions (VxDs) meetings.
- “DxDs” meetings to enable scientific and development discussions.
- Therapeutic areas (i.e. oncology, CNS, cardiovascular).