Registration/ Bringing into compliance procedures in accordance with EAEU legislation

PromoSolution provides services for the GAP analysis of documents provided for mentioned procedures, preparation of the additional documents in accordance with the EAEU requirements and registration dossier submission for EAEU decentralized procedure, mutual recognition procedure and brining into compliance procedure in Belarus as a reference state or country of recognition.

In addition, Promosolution provides the service for the development of such part of registration dossier as Summary of Products Characteristics, Patient Information Leaflet and Normative Documentation in accordance with EAEU requirements.