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Medical Product Regulatory Services In Usa Washington
2 services found
by:Intertox, Inc. based inSeattle, WASHINGTON (USA)
International registration dossiers – Provide guidance and support for the development, preparation, and submission of International regulatory marketing authorization submissions. U.S. FDA Agent - Act as a U.S. Regulatory Designated Agent for international organizations and serve as a direct liaison with the FDA. We also submit required documentation for establishment and product ...
by:Intertox, Inc. based inSeattle, WASHINGTON (USA)
Strategic Planning – Develop approval strategies including Chemistry Manufacturing and Controls (CMC) and non-clinical and clinical programs. FDA Liaison – Provide guidance and/or serve as a direct liaison with the FDA for the coordination of Prescription Drug User Fee Act meetings. Non-clinical Regulatory Support – Manage Investigational New Drug Applications’ toxicity ...