REGULATORY AFFAIRS


ADAX assists domestic and global pharmaceutical and biotech industries in achieving its key objectives:

  • Be first on the market – obtaining Marketing Authorization for medicinal products in an efficient manner
  • Remain on the market as long as possible – mmaintenance of the life cycle of products as long as reasonably possible

We can support you in::

  • Regulatory strategy advice
  • Pharmacoeconomics: compilation of applications for Maximum allowed prices (MAP) and Extraordinary Higher Prices (EHAP)
  • Reimbursement submissions
  • Registration documentation for centralized or national submissions and lifecycle management (paper and electronic submissions)
  • Development Safety Update Report (DSUR), Pharmacovigilance System Master File (PSMF), Periodic Safety Update Report (PSUR), Risk Management Plan (RMP)
  • Readability tests (full user test, bridging, focus test)
  • Product information: quality review of documents (QRD) with conversion, translation, proofreading
  • Dear Health Care Provider (DHCP) letters translation, proofreading
  • Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) management
  • pharmacovigilance – (Hyperlink)