Sometimes, the best regulatory meeting is the one that doesn’t happen. FDA Q-Submissions (including Pre-Subs), IDE meetings, and other touchpoints pay off only when the objective is sharp, the questions are answerable, and the evidence is organized around a single story. Programs stall when sponsors walk in with a broad wish list, unclear asks, or briefing documents that invite new concerns. HIC’s regulatory meeting teams start by understanding your technology, your business goals, and the specific decision you need from the Agency. From there, we help shape a focused meeting strategy that aligns questions, background information, and proposed positions with the right meeting type and with current FDA expectations.
HIC support does not come from scripts or generic checklists. Seasoned regulatory experts including former FDA reviewers work directly with your subject-matter experts to build a briefing package that matches how reviewers read: concise problem framing, page-referenced data, and clear options. We help structure the slide deck, speaking roles, and backup materials so the discussion follows a logical path and stays grounded in the record. After the meeting, we review the official minutes, resolve ambiguities, and translate FDA feedback into specific updates for protocols, testing plans, labeling, and timelines, so you leave with direction that can be acted on, not just notes.
Meetings that generate actionable direction
- We engineer questions that elicit bounded, actionable guidance and anchor them to a coherent regulatory narrative.
- Former FDA officials and senior regulatory leads with deep device experience shape the briefing package and talking points so reviewer reasoning and evidence meet in the same place.
- Targeted rehearsals pressure-test answers, assign roles, and set decision trees that keep the meeting focused and credible.
- Post-meeting, we turn minutes into traceable actions with owners and timelines, maintaining alignment through the next regulatory milestone.
