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)