Regulatory expertise

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 drug development phase throughout all phases of clinical development to market authorization and product maintenance. Our senior staff offers 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
  • Country-specific documentation and submissions
  • End-of-trial declaration
     

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 test
  • Parallel import
     

Product Maintenance

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