Regulatory Affairs

At Medivant Pharma, we provide comprehensive regulatory submission support to ensure your clinical trials meet all regulatory requirements. Our services include:

1. Submission Preparation
   
   • New Drug Applications (NDAs).
   • Biologics License Applications (BLAs).
   • Clinical Trial Applications (CTAs).
2. Document Management
   • eCTD Compilation and Submission.
   • Regulatory Dossiers.
   • Module 2-5 Preparation.
3. Compliance
   • Regulatory Guidelines Adherence.
   • Quality Control and Review.
     
4. Communication
   • Regulatory Agency Liaison.
   • Response to Regulatory Queries.
5. Consulting
   • Regulatory Strategy Development.
   • Training and Support.