Can anyone recommend a Russian Delclarant/company to support our in-country representation requirements and serve as point of contact for an In vitro Companion (CDx) system registration and certification procedures. The Declarant must be able to assume responsibility for a manufacturer’s device/drug and liaise with the Russian regulatory authorities and insure that the needs of the technical test laboratories and clinical centers are relayed to the manufacturer as well as perform all registration and certification requirements.
Thanks in advance for your help
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Robert Wilkinson
President
Resolute Regulatory Affairs Consulting Service, Inc
Port Barrington IL
United States
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