Pre-submission meetings with the FDA and other regulatory agencies are an important aspect of the medical device regulatory process. It is an important opportunity for medical device manufacturers to discuss their product and regulatory strategy with the FDA and other Health Authorities and receive feedback on the best path forward. We offer multiple services under this category
Pre-sub meeting preparation: We provide services for the Pre-Sub packages including the review of the technical documents, compilation of the comprehensive technical package and finalization of the package and submission with the HA for the meeting.
Pre-sub meeting: We provide services to represent the client in HA meetings and interact with the agency for collation of the responses to the queries. We represent the clients by providing the SME support by discussing the potential regulatory issues and feedback on the regulatory strategy.
Implementation of HA recommendations and Suggestions: We provide support to evaluate the recommendations shared by the agency on the strategy, product related technical aspects and the suggestion for potential regulatory issues and develop a detailed plan for implementation