Regulatory

Gedeon Richter China has a highly experienced, fast, efficient and reliable regulatory team located in Beijing and Shanghai performing amongst others:


  • Registration of Rx/OTC, medical device, foodstuff   and cosmetic products

  • Registrations and renewals for import licenses

  • Local clinical trial management (bioequivalency study to phase III double blind study) for registration purposes

  • Supplementary applications and one time permits

  • Indication extensions

  • Drug inspections, Pharmacopeia specification changes


We have considerable experience and a proven track record in above transactions, significantly beating industry standards in timelines and costs.