Health Authority Meeting Support
Health Authority Meeting Support
Strategic Guidance and Expert Preparation for Successful Regulatory Interactions
Engaging with global health authorities—such as the FDA, EMA, MHRA, or PMDA—is a critical milestone in the development and approval of pharmaceuticals, biologics, and medical devices. These meetings provide an essential opportunity to gain regulatory clarity, align on development plans, and de-risk your pathway to approval.
At Bionetwork Consulting, our Health Authority Meeting Support services are designed to help you prepare, manage, and navigate these high-stakes interactions with confidence and precision. From early engagement to post-meeting follow-up, we ensure your messaging is clear, your documentation is complete, and your team is ready to make the most of every regulatory opportunity.
Our Services Include:
Meeting Strategy & Planning
We help you determine the optimal timing, format, and type of meeting (e.g., pre-IND, Type B, Scientific Advice) based on your development stage and goals. Our regulatory experts guide you in framing key questions and positioning your program effectively.
Briefing Package Development
We assist in drafting, reviewing, and finalizing the full briefing package—including the background information, development history, clinical and nonclinical data summaries, and specific regulatory questions. We ensure your submission is clear, compliant, and compelling.
Regulatory Question Framing
Crafting precise, focused questions is critical to getting the guidance you need. We help you formulate questions that elicit actionable feedback while avoiding ambiguity or regulatory misalignment.
Meeting Logistics & Coordination
From submitting meeting requests to coordinating with regulatory agencies and managing timelines, we handle the logistics so your team can focus on strategy and content.
