Services

GMP - (Good Manufacturing Practice) - a system of rules, regulations and guidelines for the production of drugs, medical devices, articles diagnostic purpose, food additives, active ingredients.

Registration of a new product is  the first step of launching drug to the market of the Russian Federation. The registration is a state procedure of drug quality, efficiency and safety evaluation to obtain an approval for medical use of a drug in the Russian Federation.

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.

During the registration of medicinal products and clinical research organizations have to work with the medical and pharmaceutical documentation in multiple languages, especially when the manufacturer of the drug or one of its active ingredients is a foreign company.

Provision of daily and weekly GR Monitoring of state RF bodies regulatory functions, periodical monitoring of activities of specialized public and professional organizations, profile media in the pharmaceutical field.

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).

LDV Training Center together with European colleagues provides advisory and training services to companies wishing to improve their skills and expand knowledge in the field of GMP certification.