FDA Meeting
Strategy

Leaders in Health Authority Engagement

Why Meetings Matter

You Get a Handful of Hours With FDA. Make Every One Count.

Across an entire development program, most sponsors spend fewer than ten hours in formal dialogue with the agency. Those hours decide trial designs, endpoints, and approval pathways worth years of runway. We prepare your team for every health authority interaction: choosing the right meeting at the right time, asking questions the agency can actually answer, and converting preliminary feedback into binding alignment you can build a program on.

Have an FDA meeting on the horizon? The preparation window is shorter than you think.

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Capabilities

From Meeting Request to Binding Minutes.

We support the full lifecycle of a health authority interaction: deciding whether to meet, securing the meeting, preparing the room, and holding the agency to what was agreed.

Meeting Type & Timing Strategy

Choosing the right interaction (INTERACT, Type A, B, C, D, or Q-Sub) at the right development milestone, and knowing when not to meet at all.
Meeting Requests & Briefing Books

Meeting requests that get granted, questions the agency can answer, and briefing packages that frame the discussion before it starts.
Mock Meetings & Rehearsal

Full-dress rehearsals with former FDA reviewers playing the agency side, so the hardest questions get asked before meeting day.
In-Meeting Support

Senior leads in the room (or on the line) to facilitate, keep discussion on your questions, and read agency signals in real time.
Minutes & Follow-Through

Sponsor minutes, discrepancy resolution against official FDA minutes, and action plans that convert feedback into program decisions.
Global Health Authority Engagement

EMA scientific advice, MHRA, PMDA, Health Canada, and TGA interactions, coordinated so regional feedback builds one coherent global strategy.
Meeting Type & Timing Strategy

The Right Meeting, at the Right Milestone, With the Right Questions.

Requesting the wrong meeting type wastes a review cycle. Requesting it too early wastes the meeting itself. We map every planned agency interaction against your development milestones, then build each request around questions the division can actually commit to: specific, answerable, and sequenced so that one meeting's outcome sets up the next.

Meeting Types Supported

  • INTERACT and INTERACT LITE (early advice for novel products)
  • Pre-IND meetings (Type B)
  • End-of-Phase 1 and End-of-Phase 2 meetings
  • Pre-NDA and Pre-BLA meetings
  • Type A meetings for stalled programs, clinical holds, and disputes
  • Type C and Type D meetings for focused scientific questions
  • Q-Submissions and pre-submission meetings for devices and diagnostics
Meeting Requests & Briefing Documents

The Briefing Book Is the Meeting.

By the time you enter the room, FDA has already formed its positions from your briefing package. A strong package frames each issue, presents the data honestly, and proposes a position the division can agree with in writing. We author and pressure-test the entire dossier: the meeting request, the question set, the background sections, and your planned responses to the preliminary comments that arrive days before the meeting.

What We Prepare

  • Meeting requests engineered to secure the format you want
  • Question development and sequencing strategy
  • Full briefing package authoring or senior-level review
  • Sponsor position statements for each question
  • Response strategy for FDA preliminary comments
  • Presentation slides and opening statements
  • Written Response Only (WRO) evaluation and strategy
Mock Meetings & Rehearsal

The Hardest Questions Should Be Asked by Us, Not by FDA.

Teams rarely lose meetings on the science. They lose them on an unrehearsed answer, a contradiction between two presenters, or a concession made under pressure. We run full-dress mock meetings with former FDA reviewers on the agency side of the table, assign roles, script the first sixty seconds of every answer, and drill the questions your team hopes nobody asks.

How We Rehearse

  • Mock panels staffed by former FDA reviewers and division veterans
  • Anticipated question banks built from division precedent
  • Role assignment: who answers what, and who stays silent
  • Q&A response scripting and message discipline coaching
  • Contingency planning for adverse preliminary comments
  • Advisory Committee rehearsals with full panel simulation
  • Presenter coaching for virtual and in-person formats

Briefing book due to FDA soon? Get senior eyes on it before it locks.

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In-Meeting Support

A Senior Lead in the Room Changes How the Room Behaves.

The meeting itself moves fast: an hour, sometimes less, with preliminary comments arriving only days before. Our senior consultants join your team at the table to facilitate the discussion, keep the agency on your question list, flag when a reviewer comment is an opening rather than an objection, and advise in real time on what to concede, what to defend, and what to take away for follow-up.

On the Day

  • Meeting facilitation and time management against the agenda
  • Designated scientific and regulatory spokespersons
  • Real-time strategy calls during caucus breaks
  • Reading division signals: what FDA says versus what it means
  • Live capture of commitments, concerns, and open items
  • Support for virtual, hybrid, and face-to-face formats
  • Immediate post-meeting debrief with your leadership team
Minutes & Follow-Through

A Meeting Only Counts if the Minutes Say What You Heard.

Official FDA minutes are the binding record, and they do not always match the room. We draft sponsor minutes within hours of the meeting, reconcile them line by line against the agency's official version, and pursue corrections where the record misstates an agreement. Then we turn the outcome into an action plan: what changes in the protocol, the CMC plan, and the submission timeline, and what gets confirmed in writing before you spend against it.

After the Meeting

  • Sponsor minutes drafted within 24 hours
  • Line-by-line reconciliation against official FDA minutes
  • Requests for corrections and clarifications on the record
  • Post-meeting action plans tied to program decisions
  • Follow-up correspondence and Type D question strategy
  • Escalation strategy, including Formal Dispute Resolution (FDR)
  • Documentation of agreements for investors and board reporting
Global Health Authority Engagement

FDA Is One Voice. Your Strategy Has to Survive All of Them.

Advice from one agency can quietly contradict another: an endpoint EMA accepts that FDA questions, a comparator PMDA expects that nobody else does. We plan and execute interactions across the major health authorities as a single campaign, sequencing national scientific advice so each response strengthens your position with the next agency instead of fragmenting your development plan.

Agencies & Procedures

  • EMA Scientific Advice and Protocol Assistance (CHMP/SAWP)
  • Parallel EMA/FDA Scientific Advice
  • MHRA Scientific Advice and ILAP engagement
  • PMDA consultations and clinical trial notifications
  • Health Canada pre-submission meetings
  • TGA and other national competent authority interactions
  • Cross-agency feedback reconciliation into one development plan
Specialty Engagements

When the Stakes Are Highest.

Two situations demand more than standard meeting preparation: a public Advisory Committee vote, and a program where sponsor and agency no longer agree.

Advisory Committee Preparation

One Day in Public Decides Years of Work.

An Advisory Committee meeting is part science, part theater, and entirely unforgiving. We manage the full preparation campaign: core presentation development, panelist background analysis, mock panels with voting, rapid-response slide libraries for the Q&A, and speaker coaching for a televised, adversarial setting.

Included Capabilities

  • AdComm strategy and core message architecture
  • Core presentation and backup slide library development
  • Committee member and chair background analysis
  • Multiple full-scale mock panels with independent experts
  • Open Public Hearing and patient voice coordination
  • Rapid-response Q&A team on meeting day
Disputes & Difficult Conversations

When You and FDA Stop Agreeing.

Clinical holds, refuse-to-file letters, Complete Responses, and unresolvable division-level disagreements each have a formal path forward, and an informal one that is often faster. We help sponsors decide when to push, when to reframe, and when to escalate through Formal Dispute Resolution, then run the interaction that follows.

Included Capabilities

  • Clinical hold response strategy and Type A meetings
  • Complete Response Letter (CRL) analysis and resubmission planning
  • Refuse-to-File risk assessment and response
  • Formal Dispute Resolution (FDR) requests and appeals
  • Post-CRL Type A meeting preparation
  • Division relationship repair after contentious interactions
Who You're Working With

People Who Have Sat on Both Sides of the Table.

Our meeting teams are built from former FDA reviewers who once wrote the preliminary comments you're responding to, and industry regulatory leaders who have run hundreds of agency interactions as sponsors. You get the senior practitioner in the room, not a junior team under a partner's name.

Former FDA Reviewers

Consultants who have drafted agency meeting minutes, briefed division directors, and voted in internal pre-meeting caucuses. They know how your package is read because they used to read them.

Division-Level Pattern Recognition

Meeting strategy is division-specific. We track how individual review divisions handle endpoints, accelerated pathways, and advice requests, and prepare you for the division you actually have.

Global Agency Networks

Practitioners with direct working experience at and with EMA, MHRA, PMDA, and Health Canada, so multi-region advice comes from people who have run those procedures.

Modality and Therapeutic Breadth

Small molecule, biologic, cell & gene, device, diagnostic, and digital health programs across oncology, rare disease, neuroscience, immunology, and beyond.

Work With Us

Your Next Agency Meeting Starts Now.

Tell us which interaction is ahead of you and where the program stands. We'll match you with a senior meeting lead and respond within one business day. All inquiries are strictly confidential.

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Insights & News

Thought Leadership on Agency Engagement.

Our team's perspectives on FDA meetings, health authority strategy, and what actually happens inside the review division: coming soon. In the meantime, reach out directly with a question you'd like to see addressed.

Coming Soon

Writing Questions FDA Can Say Yes To

Why most meeting questions get non-answers, and how to structure ones that don't.

Coming Soon

Type D and INTERACT: The Underused Meetings

When the newest meeting formats beat waiting for a Type B slot.

Coming Soon

Parallel FDA-EMA Scientific Advice

When joint advice accelerates a global program, and when it backfires.