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REGULATORY SERVICES
The Regulatory & Clinical Research Institute, Inc. (RCRI) offers comprehensive global biologics, IVD, and medical device regulatory consulting services. Our U.S. and international capabilities include but are not limited to services listed below.
U.S. Capabilities
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Strategic planning - Clinical trial regulatory submissions
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Premarket Notification (510k)
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Premarket Approval Application (PMA)
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Investigational Device Exemption (IDE)
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Investigational New Drug (IND)
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New Drug Application (NDA)
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Biologic Licensing Application (BLA)
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Master files
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Combination products
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Humanitarian Device (HUD)
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Humanitarian Device Exemption (HDE)
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Medical Device Reporting (MDR) and complaint handling
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Product Development Protocol (PDP)
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Labeling
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Interpretation of standards and guidelines
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Preparation and representation at FDA advisory panels and regulatory agency meetings
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Postmarket surveillance protocols
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Registration and licensing
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Import certificates and registration
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Expert reports
International Capabilities
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Strategic international planning
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Master files
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Design dossiers
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Technical documentation and files
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Expert reports
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Labeling
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Interpretation of standards and guidelines
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Export certificates and registrations
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Registration and licensing
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Vigilance reporting
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Postmarket reporting
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