Development Stage

Regulatory Affairs Support

Docent Pharma consultants assist companies to plan and manage their pharmaceutical and medical product development programs and regulatory requirements.

Docent Pharma is your one-stop source for regulatory expertise. Our qualified experts or consultants provide end-to-end regulatory services across lifecycle management from product development (R&D, Pre-clinical, Clinical Trials) to registration/marketing application and post approval. 

We do this by helping our clients with:

  • Pre-submission activities such as Controlled Correspondences, Meeting Requests (Pre-IND/Pre-NDA/Pre-BLA/Pre-ANDA meetings), Pre-submission Facility Correspondence (PFC), CGT (competitive generic therapy) Designation, National and EMA scientific advice. 
  • Giving input into chemical and pharmaceutical, preclinical and clinical plans for the development of products to ensure that they meet regulatory expectations.
  • Advise on the appropriate route of submission to market. 
  • Assistances in IMPDs/CTAs, INDs, IBs, Orphan Drug Designation (ODD), Initial Pediatric Study Plan (iPSP), Fast Track and Expedited Review etc.