As you know Regulatory Affairs activities extend far beyond getting marketing regulatory affairs consulting in russia
authorizations for a product portfolio. Registration of a product is always a challenging task in Russia and making it clear, risk-free and predictable is one of the key tasks for business.
Regulatory affairs can be divided to following sections:
A. Regulatory Strategy elaboration that consists of:
Regulatory conditions analysis for particular product or product portfolio;
Gathering and analysis of regulatory intelligence (registered competitor products, their ongoing registration projects, variations etc.);
Forecast of regulatory actions and preparation of registration timeline;
Allocation of needed resources and forecasting budget;
Periodical regulatory strategy review.
B. Elaboration of drug registration projects that typically consists of:
preparation of registration dossier;
management of dossier translation and expert review of it;
coordination of preclinical studies;
regulatory coordination of registration clinical studies;
regulatory management of product’s quality expertise during registration;
considering of local SmPC/ PIL edition during “benefit-risk” state expertise;
obtaining the registration certificate.
C. Regulatory affairs support for registered products:
regulation of prices; certification and declaration of quality conformity;
control and coordination of state quality control inspections;
regulatory coordination of market access and pharmacoeconomics projects;