You are here: Home Registration of Active Pharmaceutical Indredients (API) in Russia Registration of Active Pharmaceutical Indredients (API) in Russia
+7 495 109 8808 +7 985 908 5818 info@re.gth.gd.gth.rug.com
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:
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.