Registration / re-registration / variations of the registration dossier
The sale of pharmaceutical products in the territory of Ukraine is possible only after their registration. The process of registering pharmaceutical products is always very cost-intensive and time-consuming, that’s why you always need a professional approach, careful examination of the supporting documents and accurate completion of registration dossiers in accordance with the legislation. It is important to take into account the relation of the manufacturer’s country to the PIC/S countries, because during registration of pharmaceutical products it is necessary to provide validation of GMP certificate. If such certificate is not available, it is necessary to undergo an audit and inspection of the manufacturing site.
After careful examination of the documentation package provided by the Customer, we will develop and implement the best strategy in order to find a solution to your problem: we will prepare or draw up necessary documents to the dossier, prepare the application and complete the dossier according to CTD format, provide documents support during the preliminary and specialized examination, help with the reply to the examiner’s observations and we will carry out the procedure of registration of the pharmaceutical product. If necessary, we will assist with the reregistration or amendment of the registration documents of your pharmaceutical product in accordance with the current legislation of Ukraine.