Pre-IND & Type B meeting preparation
One shot at the meeting. We make it count. Briefing books, FDA-style draft answers, and a mock session, grounded in every approved label and meeting precedent in your indication.
Most sponsors walk into Pre-IND meetings under-prepared
Sponsors typically have weeks, not months, to prepare. The team doing the prep often hasn't been in an FDA meeting before. Briefing documents read like internal R&D summaries, not regulatory submissions. The questions asked aren't the ones FDA will actually answer.
The result: a meeting that confirms what you already knew, or worse, raises new issues you weren't ready to address. You walk out without the alignment you came for, and the next interaction is six months away.
Every artifact you need, delivered as a package
Meeting request letter
FDA-formatted, including proposed agenda, attendee list, and product context. Submitted with full traceability.
Briefing document with precedent analysis
Full briefing book (typically 40–80 pages) with comparable program outcomes, every approval pathway in your indication, and the relevant CDER/CBER review precedent.
Question framing & FDA-style draft answers
3–6 questions structured for binary, actionable FDA responses. Each with our anticipated answer and the precedent supporting it.
Mock meeting & coaching session
2-hour mock with a senior regulatory specialist playing the agency. Live coaching on tone, what to concede, what to defend.
Three things you don't get from a traditional consultant
Every comparable Pre-IND outcome, indexed
Our proprietary platform indexes 100K+ trials, every FDA approval label, and guidance correspondence in your indication and modality. We can tell you what FDA agreed to, pushed back on, or required for comparable programs. Most consultants reproduce this knowledge from memory.
Senior specialist, in-house review
A senior regulatory specialist matched to your modality and milestone leads the briefing book, slides, and mock. Our in-house clinical and regulatory team scopes the engagement, reviews drafts, and signs off before delivery.
Fixed fee, fixed timeline
From $55K for a complete Pre-IND package. No T&M creep. No surprise invoice for the eighth round of revisions. You see deliverables and price before you sign.
From kickoff to FDA-submitted package
Discovery & precedent
Kickoff call, data room access, and indication/modality precedent pulled from the Rightview platform.
Briefing book draft
First full draft of the briefing book and meeting request, shared in working format.
Question framing & revision
Questions finalized with FDA-style draft answers. Two revision cycles built in.
Mock & submission
2-hour mock meeting, final package, and submission-ready files delivered.
Test the relationship, or commit to the full package
Pick the on-ramp that fits your milestone and signing authority. Both come with a fixed-fee SOW in 24 hours.
Pre-IND scoping memo
A focused regulatory brief to validate your Pre-IND direction before committing to a full package.
- 15–20 page strategic brief
- 2 questions framed FDA-style with anticipated answers
- Modality and indication precedent summary
- 1-hour readout call with regulatory specialist
Full Pre-IND package
Everything you need for a productive FDA meeting, end to end.
- Full briefing document (40–80 pages)
- 3–6 fully framed questions and FDA-style draft answers
- Meeting request letter, formatted and submission-ready
- 2-hour mock meeting and live coaching
Pre-IND meeting in the next quarter?
Send a note about your program. You'll get a fixed-fee proposal back within one business day, with timeline, fee, and proposed staffing.