RegMed provides an extensive range of regulatory and clinical services for medical device and pharmaceutical companies entering the Russian and Eurasian Union (EAEU) market, guiding clients through the marketing authorisation (MA) procedure and providing services such as clinical trials and good manufacturing practice (GMP) inspections.
Our services for the organisation and support towards registration of pharmaceutical products and substances include registering both original and generic pharmaceuticals, as well as amendments to the dossier such as changes to safety profile or expansion of indications. We prepare the document package to acquire authorisation for clinical trials of the pharmaceutical product.
We also arrange and monitor clinical trials of the pharmaceutical product as part of international multi-centre clinical trials or for its registration in the Russian Federation, as well as preclinical studies of the pharmaceutical product. Additionally, we can prepare and submit periodic safety reports, as well as confirm the product’s registration.
RegMed offers state registration of veterinary pharmaceuticals, as well as feed additives of foreign and domestic manufacturers.
We can also conduct preliminary laboratory studies and amend a market authorisation based on factors such as shelf life, holder, place of manufacture and product name, as well as confirm the registration of the pharmaceutical for veterinary use.
We offer a declaration of conformity, a document to certify the product meets applicable requirements, for medical devices and hygiene products, as well as perfume and cosmetics. The business whose name the declaration is issued is accountable for the accuracy of the information.
Furthermore, we can also arrange for a voluntary certificate of compliance as part of the full range of services we offer our customers. Voluntary certification is often carried out to authorise the declared properties of biologically active additives.
Our company provides a complete solution, through various stages, for the task of medical device registration, from the preliminary assessment of dossier to the addition of the medical device in the state registry, acknowledged by the Marketing Authorisation.
We can carry out an initial evaluation of the dossier, providing client consultation, while assessing the completeness of the materials submitted, as well as their conformity with registering agency requirements. We can come to an agreement with the client based on the cost of registration.
During the testing phase, we can obtain a permit to test samples, in the case of medical devices manufactured by foreign companies and conduct toxicology and technical studies, as well as tests for approval of measuring instrument type, if appropriate.
Evaluation of all dossiers is authorised by organisations at the Federal Service of Surveillance on Consumer Rights Protection and Human Wellbeing of the Russian Federation (Roszdraynadzor), where they are compiled and finalised in agreement with regulatory requirements.
We conduct bioequivalence studies and clinical trials throughout Russia, undertaking a vast array of procedures, extending from attaining clinical trial approval to final report valuation.
All official documents for clinical trials are put together by professionals in the field of scientific medical proficiency. All documents conform to ICH GCP standards set out by several federal agencies, including EMEA, FDA and Ministry of Health and Social Development of the Russian Federation. We can design research documents for clinical trials carried out by our company, as well as for self-governing projects.
We possess an extensive, regularly updated database of regional and federal clinical sites. Through long-term cooperation with various medical institutions and investigators who focus on conducting clinical trials in diverse areas of medicine, we can quickly discover the most appropriate clinical sites for even the most intricate research.
RegMed prof was established in 2000, striving to meet the challenges of regulatory submissions throughout Russia for medical devices and pharmaceuticals. Our company’s highly qualified project managers offer services to meet and exceed customer expectations.
RegMed prof has formed long-term relationships with over 20 laboratories, research institutes and test centres, offering a unique project management system.
Telephone: +7(903)748-60-35 / +7(495)120-11-64