Local Regulatory Knowledge and Experience

 

  • Extensive experience in US FDA, EU EMA and EU national regulatory authorities including more than 30 registered drug substances
  • Extensive experience with Japan PMDA regulations including more than 8 registered drug substances
  • Experience with new DMF procedure and several registered drug substances in China
  • Experience and several registered drug substances in emerging markets like Brazil, Korea, Russia, South East Asia
  • Several drug substances registered in more than 100 markets