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REGULATORY SERVICES
Go Global with Less Effort
Reaching beyond the U.S. market may seem like a daunting task requiring submissions, presentations, and negotiations in foreign languages in countries with different business cultures.
The Regulatory & Clinical Research Institute, Inc. (RCRI®) will guide you through the regulatory process in major international markets and develop a plan for securing approvals in countries most amenable to your product.
RCRI has achieved successful approvals with major regulatory agencies and notified bodies worldwide including but not limited to:
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European Notified Bodies (CE mark)
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Therapeutic Products Programme (TPP) (Canada)
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Medicines and Healthcare Products Regulatory Agency (MHRA) (United Kingdom)
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Ministry of Health, Labour and Welfare (Japan)
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Therapeutic Goods Administration (TGA) (Australia)
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Ministry of Health (Mexico)
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State Food and Drug Administration (SFDA) (China)
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