Consulting on Pharmaceutical Regulatory Affairs and Registration Strategy

Regulatory Strategy in Russia. Regulatory Consulting in Russia

As you know Regulatory Affairs activities extend far beyond getting marketing 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:

1. Regulatory conditions analysis for particular product or product portfolio;
2. Gathering and analysis of regulatory intelligence (registered competitor products, their ongoing registration projects, variations etc.);
3. Forecast of regulatory actions and preparation of registration timeline;
4. Allocation of needed resources and forecasting budget;
5. Periodical regulatory strategy review.

B.  Elaboration of drug registration projects that typically consists of: 

1. preparation of registration dossier;
2. management of dossier translation and expert review of it;
3. coordination of preclinical studies;
4. regulatory coordination of registration clinical studies;
5. regulatory management of product’s quality expertise during registration;
6. considering of local SmPC/ PIL edition during “benefit-risk” state expertise;
7. obtaining the registration certificate.

C.  Regulatory affairs support for registered products:

1. regulation of prices; certification and declaration of quality conformity;
2. control and coordination of state quality control inspections;
3. regulatory coordination of market access and pharmacoeconomics projects;
4. regulatory assiatance for post-approval clinical studies;
5. regulatory assistance for launches, marketing materials and campaigns;
6. regulatory pharmacovigilance support.

Every phase and step in regulatory affairs should have minimal amount of mistakes and misunderstandings due to considerable time needed for any regulatory change to take effect. Large inertia accompanies any regulatory decision.

The opposite side of regulatory affairs in some cases is moderate to low amount of predictability and lack of information concerning, for example, new innovative products that need large update of the registration dossier or local registration studies with unique design.

That is why professional regulatory consultancy could be essential, time and money-saving service in any stage of regulatory project, with its key role during project feasibility evaluation. And our seasoned experts would give you our Clear Regulatory Answers for your business.