We understand the regulatory landscape and can help you devise a strategy to fulfill regulatory obligations.
Regulatory framework is becoming more and more stringent and complex as far as pharmaceuticals for human use
are concerned.
From regulatory viewpoint, we can help you in the following areas:
Framing responses to queries from regulatory agencies
Scientific input in interactions with regulatory agencies
Dossier development and management for the products
Identification of Medicinal Products/Extended EudraVigilance medicinal product dictionary