Regulatory Affairs

The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product maintenance. Our senior staff offer more than 30 years of successful submission experience, interacting with regulatory agencies worldwide.

Our services include:

Clinical Studies 

  • Global Scientific Advice
  • Preparation and submission of CTA/ITA, IND, PMA/510(k)
  • Interaction with regulatory agencies world-wide
  • Orphan Drug Designations
  • Pediatric Investigational Plans (PIPs)
  • Country-specific documentation and submissions
  • End-of-trial declarations
     

Application of Marketing Authorization 

  • Preparation and submission of marketing applications (CTD, NDA, BLA, NDS, MAA and equivalents)
  • Compilation of submission files- all procedures
  • Labeling proposal
  • Readability testing
  • Parallel import
     

Product Maintenance

  • SPC/product leaflet/labeling updates
  • FASS editing
  • Variations