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Medical Product Regulatory Services In Usa
3 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 ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
HingeClinica is a world class partner for Medical Device services. We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and ...