Clinical Trial Regulatory Submission Services
Sofpromed provides regulatory submission services for clinical trials to be conducted in the following countries, among others:
- United Kingdom: Medicines & Healthcare products Regulatory Agency (MHRA)
- Australia: Therapeutic Goods Administration (TGA)
- Europe: Clinical Trials Information System (CTIS)
- Spain: The Spanish Agency of Medicines and Medical Devices (AEMPS)
- France: National Agency for the Safety of Medicines and Health Products (ANSM)
- Germany: Federal Institute for Drugs and Medical Devices (BfArM)
- Italy: Italian Medicines Agency (AIFA)
- Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
- Czech Republic: State Institute for Drug Control (SÚKL)
- Slovakia: State Institute for Drug Control (SÚKL)
- Greece: National Organization for Medicines
- Georgia: State Regulation Agency for Medical Activities (LEPL) of the Ministry of Labor, Health, and Social Affairs
Please contact us if you need clinical trial regulatory submission services in countries not included in the above list.