Elena

Biography

 Expert at Pharmaceutical and Medical device area in Russian and CIS market. Experience in regulatory field - more then 14 years. We represent our consulting services in the area of circulation of drugs, substances, medical immunobiological products, medical devices and medical equipment. Two documents required for market drugs and medical devices in Russia: 1) Registration Certificate 2) DOC  We offer you a complex of services including the individual, multilateral approach to the solution of your targets and goals. All kinds of services appear according to the current legislation of the Russian Federation and in guaranteed shot time. We will be glad to cooperate with you in the following directions: 1. Registration of drugs and immunobiological products (obtain Registration Certificate from MOH), develop Normative documentation, IFU, labels according to requirements of Russian Authorities, obtaining Declaration of Conformity from Certification centre 2. Substances approval 3. Registration of medical devices and medical equipment in Roszdavnadzor(obtain Registration Certificate from RZN), develop Technical documentation, IFU, labels according to requirements of Russian Authorities, obtaining Declaration of Conformity from Certification centre 4. Post-registration changes in the regulatory documents (RD) 5. Obtaining import permits for samples delivery 6. Development of corporate design and prototype of medical device and drug packaging We promptly and clearly accompany you, since competent consultation by preparation of a necessary package of documents till receiving of a registration certificate and permits of the RF Ministry of Health and Roszdravnadzor.

Research Interest

 In Pharmaceutical science