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REGULATORY SERVICES
The Regulatory & Clinical Research Institute, Inc. (RCRI®) offers comprehensive global regulatory 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
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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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