In accordance with the existing Russian legislation dietary supplements are subject to obligatory state registration. On May 28, 2010 the he Commission Of The Customs Union approved the list of goods subject to mandatory state registration and on 1 July 2010 «Uniform list of goods" entered into force.
Pharmacovigilance, or monitoring of drug safety, is the science and activity aimed at identifying, evaluating and preventing adverse reactions (HP) or any other possible problems associated with drugs. The pharmacovigilance system is one of the components of the quality management system (QMS).
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Due to the changing market conditions, at the present moment and the absence of possibility to conduct on-site inspections, our team of professional experts from the LDV-group company performs remote pre-inspection GxP (GMP, GDP, GLP, GVP) audits, for compliance with the requirements of the Russian GMP Rules and EAEU GMP, gives recommendations on eliminating existing discrepancies, assists in adjusting corrective action plan (CAPA). We are planning to conduct on-site consultations (GMP audits) after the pandemia, educational seminars, and lectures, both for Russian enterprises and for foreign companies engaged in the design, construction, and production activities. Our experts are ready to promptly help you in obtaining certificates, Drug Products, API, and BAA registration, in accordance with the law and all necessary requirements.