Regulatory Strategy 

We help companies develop realistic regulatory strategy for all stages of drug development:
  • Non-Clinical Toxicology to First In Man 
  • Phase I thru Phase III
  • Post Market Surveillance/REMS
A Precisely Developed Regulatory Strategy Lays the Foundation of Your Development Pathway, Adding Value Throughout Your Product Lifecycle.
We help with:
Establishing A Regulatory Path
  • For new drugs, create or assist with the refinement of regulatory strategy
    • ​Expedited programs, including Fast Track, Breakthrough therapy, Orphan drug designation
    • Develope approval strategies in the multifaceted 505(b)(2) drug development environment 
  • For Generic Drugs - ANDA or 505(b)(2), Citizens Petition, P-IV, First-to-file
  • Manage Loss of exclusivity
  • Lifecycle management strategy
Agency Meeting Preparation & Support
  • Assist with preparations for FDA and Advisory meetings​​
  • Meetings with EMA, FDA  for all phases of product development
  • Represent clients in interactions with FDA
  • Advise on regulatory options and potential pathways
Regulatory Submission Support:
  • Guidance of effective CMC Development
  • Technical Writing
  • Provide clients with an ‘FDA style’ review of their draft IND, NDA, ANDA, (505)(b)(2) and BLA submissions
  • Assess likelihood of regulatory approval
  • Assess risk associated reasons for non-approval

© 2023 by James Consulting. Proudly created with