Strategic Regulatory Engagement
Direct engagement with health authorities can significantly impact regulatory success. Pre-submission meetings provide opportunities to clarify expectations and address potential concerns before they become review deficiencies.
RegOps brings extensive experience in health authority engagement to every interaction. We help you prepare communications that elicit useful agency feedback, structure meetings that address your key questions, and respond to agency inquiries in ways that resolve concerns efficiently. Our approach ensures that every interaction advances your regulatory objectives while building constructive relationships with the agencies that authorize your devices.
Our Capabilities
Expert support for all types of agency interactions.
End-to-end support for FDA Q-Submissions and EMA scientific advice. We develop meeting requests, prepare briefing documents, formulate targeted questions, and coach teams for discussions.
Preparation for early-stage health authority consultations on development programs, regulatory pathways, and clinical study design. We help you maximize value from these interactions.
Development of responses to FDA Additional Information requests and Notified Body questions. We craft responses that thoroughly address concerns while protecting your position.
Support for FDA Advisory Committee meetings including briefing document development, presentation preparation, and anticipated question analysis for public advisory settings.
Support for formal dispute resolution mechanisms when initial regulatory decisions require challenge. We help you present scientific and regulatory arguments effectively.
Support for interactions with EU Competent Authorities and Notified Bodies including audit preparation and response. We facilitate productive dialogue within the European regulatory system.
The RegOps Advantage
We approach every interaction with clear objectives and thorough preparation to elicit the specific feedback you need.
Strategic Preparation
We craft meeting requests, briefing documents, and presentations specifically designed to drive productive discussions.
Agency Insight
Our experience provides perspective on how agencies approach reviews and what concerns they prioritize.
Communication Excellence
We craft clear, concise regulatory communications that address agency questions directly without unnecessary complexity.
Relationship Management
We help you build constructive ongoing relationships with regulatory contacts, establishing trust for future submissions.