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Synergy provides medicine / medical device registration services as per requirements of the local regulatory authorities while ensuring the process is executed with precision and professionalism.
Synergy provides registration services for medicines, medical devices and dietary supplements in the Russian Federation, the EAEU and CIS countries in accordance with the local RA requirements. We use our knowledge, experience and expertise to guarantee our clients that the process is executed with precision and professionalism.
We will conduct a dossier gap-analysis and tailor the dossier to meet all local regulatory requirements. During the submission we will provide RA expertise support (e.g. response to RA requests, provision of additional data/documents, etc.) and Import/Export services supporting marketing authorization application (drug samples, lab kits import, etc).
The drug registration dossier submitted to the local regulatory authorities includes several documents, such as mandatory data from local clinical trials, as well as mandatory local Good Manufacturing Practice (GMP) certificates from a foreign manufacturer requesting a marketing authorization.
Synergy’s local-specific GMP certification regulatory support includes tailoring the production site Trial Master File (TMF) as per local regulatory requirements, preliminary site audit, TMF submission and RA GMP-inspection support.