The MDU Regulatory Affairs Unit offers operational 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 offers more than 15 years of successful submission experience.

Our services include:

Clinical Studies 

  • Global Scientific Advice
  • Preparation and submission of CTA/ITA, IND, PMA
  • Interaction with regulatory agency
  • 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

Product Maintenance

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