AI-native Pre-IND prep
You do the science. Volta handles the rest.
From your data room to a submission-ready Pre-IND package. AI assembles, experts validate, you submit.
- Milestone-based pricing
- Expert-reviewed
- Evidence-linked
- Secure intake
Regulatory work slows science.
Pre-IND preparation is manual, expensive, and delayed. Volta streamlines the path from source documents to meeting materials.
The hidden cost
The bottleneck isn't science. It's the handoff between evidence, narrative, and review.
Momentum stalls when source documents, regulatory language, expert edits, and sponsor approval live in separate workstreams.
- 01
Manual assembly
Program teams manually transform source documents into regulatory narratives.
- 02
Scope creep
Work expands beyond the original timeline, budget, and scope.
- 03
Evidence gaps
Unsupported claims cause review friction and late-cycle rework.
What Volta changes
One path from source documents to reviewed meeting materials.
Source documents organized
Program files enter a structured workspace, not another folder chain.
Drafting from evidence
Our AI platform assembles sections with sources attached to every claim.
Experts review judgment
Domain reviewers flag gaps, refine language, and approve revisions.
Sponsors approve handoff
Your team receives briefing materials, source links, and review notes.
We don't remove regulatory judgment. We remove the coordination drag around it.
The Volta Workflow
From program documents to a reviewed Pre-IND briefing package in four steps.
Secure Data Room
Upload nonclinical, CMC, clinical, and program documents to a structured workspace.
Agent-Assisted Drafting
Volta drafts Pre-IND sections from source material and links claims to supporting documents.
Expert Review
Regulatory, CMC, nonclinical, and clinical experts review for accuracy, logic, and gaps.
Meeting-Ready Package
Receive a Pre-IND briefing package with source links, expert notes, and review history.
What Volta delivers
A complete, reviewed Pre-IND meeting package ready for sponsor review.
Complete package
Briefing materials, domain summaries, and traceability in one handoff.
Volta transforms source documents into a Pre-IND briefing package with cited narratives, prioritized questions, and expert review notes.
- Core briefing narrativeDomain-specific summariesSource links and review notes
Briefing package
Pre-IND briefing book
A meeting-ready draft with program context, development rationale, sponsor questions, and evidence links.
Evidence summaries
Nonclinical study summary
Pharmacology, PK, and toxicology synthesized from source studies, with assumptions and gaps called out.
Evidence summaries
CMC narrative
Manufacturing and controls narrative covering drug substance, process, analytical controls, and open CMC questions.
Development plan
Clinical development plan
First-in-human trial rationale, design considerations, endpoints, and discussion points for FDA meeting prep.
Meeting prep
Anticipated FDA questions
Prioritized questions organized by domain, risk, and decision need for Pre-IND discussion.
Traceability
Review record
Source links, reviewer notes, and revision history so claims, gaps, and decisions stay auditable.
Pricing
Milestone-based pricing. No hourly billing.
No deliverable, no bill. You pay against completed milestones, not hours — so incentives are aligned, costs are predictable, and we carry the execution risk.
Built for sponsor approval before agency use.
Delivered with source links and expert notes; sponsors resolve gaps and retain final responsibility for FDA material.
Built for regulation.
Our AI platform drafts from your documents. Experts review. Claims stay linked to evidence.
Volta anchors work to source documents, domain review, and sponsor approval. Our AI platform assists, never decides.
Evidence-linked
Claims stay connected to supporting source documents for sponsor review.
Expert review
Experts validate scientific accuracy, regulatory logic, and gaps before delivery.
Milestone-based pricing
You only get a bill if we deliver. No hourly billing — you pay when defined deliverables are done.
Our AI platform drafts from your documents. Experts review. Claims stay linked to evidence.
Experts where you need them.
Volta routes sections to reviewers with direct domain experience. Experts review drafts, flag gaps, and deliver sponsor-ready revisions.
- Regulatory
- Nonclinical
- CMC
- Clinical
- Pharmacology / PK
- Biostatistics
Regulatory
strategy
CMC
manufacturing
Clinical
development
Apply to review
Share your name and email and we'll reach out about matching review work to your domain.
Start your next filing.
Milestone-based pricing — you only get a bill if we deliver. Domain review. Evidence-linked delivery. A scoping call delivers clear next steps.