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.