Regulatory Submission Preparation and Management
Obtaining regulatory approval to market products can be a time-consuming and often frustrating process. Regulatory requirements vary worldwide. Expert preparation and coordination are required to ensure complete, concise and accurate submissions. Foresight Regulatory Strategies, Inc. assists companies in regulatory submission preparation and management by providing the following services:
• Determination of regulatory requirements necessary to develop a plan to receive and maintain marketing approval
• Management of relations with national regulatory authorities and notified bodies; guidance during meetings.
• Serve as authorized agent for foreign and U.S. based clients
• Preparation review and support of U.S. and international regulatory submissions/dossiers such as:
◊ PMAs, 510(k)s, NDAs, ANDAs, including amendments and supplements
◊ Annual reports.
◊ Technical Files for CE marking
◊ Other international product dossiers and marketing applications
◊ Medical Device/Adverse Experience Reports
◊ Applications to conduct clinical studies, such as IDEs and INDs
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