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