Top
 

Regulatory Support 

 
shutterstock_58252732.jpg
 
 

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).