Regulatory Affairs

Regulatory Affairs occupy a central role in securing early products' entry to market. Our team ensures compliance with regulations across different markets and enables understanding and interpretation of the dynamic regulatory landscape through:

  • Established knowledge of local regulations ensuring
    • Submitted files are compliant with the requirements
    • Approvals are within set timelines at convenient price
  • Strategy development and planning of the marketing authorization dossiers
  • Expertise in national and centralized registration procedures
  • Effective monitoring of variations and renewals ensuring continuous product supply to markets
  • Creation of eCTD dossiers
  • Optimization of submission strategies permitting:
    • On time registration and reimbursement of our products
    • Successful inspections and audits