Regulatory & Market Access

We provide the comprehensive agenda when launching a new product to the market:

• Medical data search
• Pharmacoeconomics
  • pharmacoeconomic analyses
• Regulatory
  • support in MA agenda (preparing eAF, payments, CL etc. for submission, not include preparing eCTD)
  • revisions of SmPC and PIL, development of shortened SmPC
  • preparation of artworks
  • communication with NA on behalf of MAH
  • translation of SmPC, PIL, Label
• Pricing & Reimbursement
  • elaboration of pricing and reimbursement agenda
• Communication with professional societies and public authorities

Pharmacovigilance

We provide 24/7 constant service of adverse effect notifying according to valid legislation:

• 24/7 servis via a qualified person