- Foreign manufacturers of VMPs
To whom?
- Conducting inspections in the absence of the possibility of full-time presence of the inspection at the production site
For what?
Organization of remote GMP inspection
- Individual expert advice on the procedure for remote inspection of the production site of a foreign manufacturer
- Initial assessment of documents and information about the production site
- Development of a strategy for conducting inspections of the production site
- Preparation of an Inspection Application for submission to the authorized regulatory bodies of the Russian Federation and the EEU countries
- Preparation of a set of documents in strict accordance with current legal requirements
- Assistance in organizing the payment of state duties of the Russian Federation and the EEU countries for foreign companies
- Assistance in technical translation of dossier materials
- Assistance in notarization of documents on the territory of the Russian Federation
- Representing the interests of the company in the authorized regulatory bodies of the Russian Federation in preparation for the inspection of the production site
- Submission of the Application and a set of documents to the authorized regulatory body
- Supervising the process of preparing for the inspection of the production site
- Informing the client about the progress of the process
- Timely completion of materials upon requests from authorized regulatory bodies
- Receipt of final documents by our experts in the authorized regulatory bodies of the Russian Federation and transfer of documents to the company
- Organization of remote inspection and its technical support
Procedure algorithm:
