Regulatory Submissions

Our members are experienced in preparing and submitting Regulatory applications, including INDs, NDAs, BLAs, IDEs, 510(k)s, and PMAs. We work closely with clients to ensure that submissions are complete and of high quality, reducing the risk of rejection or delays.

Pre- Approval Submissions 

  o   Medical Devices

           ▪     IRB and IDE Submissions 

           ▪     510 (k) Submissions 

           ▪     PMA Submissions 

           ▪     DeNovo and HDE Submissions 


  o   Drugs & Biologicals 

           ▪     IRB and IDA Submissions 

           ▪     NDA/BLA Submissions  

           ▪     ANDA Submissions  


Post - Approval Submissions 

  o   Medical Devices

           ▪     Post-marketing Surveillance plan 

           ▪     Panel-track supplement, 180-day supplements

           ▪     Real-time supplements, 30-day notice

           ▪     135-day supplements, and Annual submissions 


o   Drugs & Biologicals 

           ▪     Post-market Surveillance Plan 

           ▪     Post approval change submissions like change in manufacturing sites, 

                 formulation or batch size change, the addition of a new API supplier, 

                 specification/analytical method change, change in container/closure system, 

           ▪     shelf-life extension, or reduction.

          ▪         505(b) 2/Dossier preparation and submission.