Home About us Contacts

"Docmed-Service" is a company that provides professional regulatory services for legalization (registration, certification) in Ukraine. We specialize in medicinal products, medical immunobiological products, medical and non-medical products, medical techniques.

We will take over the management and organization of the process. We have the necessary knowledge, experience and skills for carrying out all necessary works, such as:

• regulatory planning and preliminary consulting;
• patent search;
• verification of the registration file for compliance with legal requirements;
• preliminary consultations with competent authorities;
• confirmation of the status and / or type of Application;
• translation of scientific, medical, technical and legal documentation;
• legal analysis and preparation of administrative documentation;
• preparation of specific national documents, including instructions for use (insert), packaging labeling and layouts;
• preclinical tests;
• clinical trials;
• preparation and registration of the registration dossier;
• submission of documentation, support;
• creation and maintenance of the pharmacovigilance system;
• creation and maintenance of the quality assurance system;
• organization of all payments;
• support of the examination process, communication with competent authorities;
• analysis of comments, preparation of recommendations for responding to comments;
• obtaining permission to import samples and standards for internal registration quality control;
• obtaining permission to import samples and standards for internal registration quality control;
• control of terms at all stages of examination;
• control of terms at all stages of examination;

02090, Kyiv, Ukraine St. Kharkivske Shose, 19 Mega City Business Center Office group No. 663