STATE REGISTRATION OF APIs

Having extensive experience in the regulatory affairs, "Mikhailyuk, Sorokolat and Partners" assists in the smooth state registration of active pharmaceutical ingredients in Ukraine. Our RA services include the entire registration procedure: compiling the dossier, submission of the finalized documents to the national Authorities, preparing responses to official requests, and securing the certificate of state registration. We also prepare instructions for use, normative documents, and labeling in compliance with local requirements, obtain permission for sample importation, and deliver samples to the regulatory bodies.

To learn more about the required documents, registration process, timeframes, and procedure nuances, please view the details for Ukraine below.