RKG provides MDs and specialized consultants with proven regulatory expertise to help to obtain global product approval and maintain filings throughout the entire product lifecycle.

Our regulatory expertise includes Domestic Biopharmaceutical Regulatory Affairs, International Biopharmaceutical Regulatory Affairs, and Medical Devices Regulatory Affairs.

Regulatory Agencies

RKG specialists and MDS have proven expertise with national and international regulatory agencies - US FDA, EMA, MHRA, MHLW and help to obtain product approval and maintain filings process throughout the product lifecycle.

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