Make progress inevitable
Pre-IND, protocols, amendments, pivotal design, and CMC for drug developers. Q-Sub, 510(k) prep, and Clinical Evaluation Reports for device developers. Drafted by senior specialists matched to your program, reviewed and signed off by our in-house clinical and regulatory team. Backed by our proprietary index of 100K+ trials, FDA labels, and guidance. Delivered in weeks, at lower cost than traditional consultancies.
Why a small team with the right software outperforms a big consultancy
Most regulatory consulting hours go to literature review, precedent search, and document assembly. Rightview's platform collapses those steps. Our leads spend their time on the judgment calls that actually shape your filing.
Precedent at your fingertips
Our proprietary index of 100K+ trials, FDA approval labels, and guidance documents, already structured and searchable. No 40-hour literature reviews charged back to you.
Senior specialists, in-house review
We match a senior specialist with the right modality and milestone background to lead the technical work. Our in-house clinical and regulatory team scopes the engagement, reviews every deliverable, and signs off before delivery.
Fixed scope, fixed price
Statement of work in a single page. No T&M creep. No surprise invoices. You see the deliverable list and the price before you sign.
Engagements we run for sponsors
Each one is scoped, priced, and delivered against a fixed timeline. Mix and match across your program.
Pre-IND & Type B meeting preparation
Get to a productive FDA meeting with a defensible position and the right questions on the agenda.
- Meeting request letter
- Briefing document with precedent analysis
- Question framing & FDA-style draft answers
- Mock meeting & coaching session
Phase 1 & Phase 2 protocol drafting
A protocol grounded in what's worked. Endpoints, eligibility, and dose escalation modeled against comparable programs in your indication.
- ICH E6-compliant protocol document
- Comparator endpoint & I/E benchmarking
- Statistical analysis plan outline
- Site & PI shortlist (optional add-on)
Mid-trial amendment packages
More than a redline. We draft the amendment, map every downstream change across sites, IRBs, vendors, and supply, and project-manage the rollout. Industry average is 260 days. We compress it.
- Tracked-changes protocol amendment
- Justification memo & risk-benefit summary
- Updated ICF, IB sections, and CRF deltas
- IRB & FDA submission-ready package
End-of-Phase-2 & pivotal design
The most consequential trial of your program. Designed against every approved label in your indication, with three options modeled before you commit.
- EOP2 briefing book & question list
- Pivotal protocol synopsis with 3 design options
- Endpoint precedent & approval pathway analysis
- Sample size & timeline scenarios
CMC documentation for novel modalities
Cell, gene, RNA, peptide, ADC, or radioligand. CMC sections built by specialists who have shipped INDs in your modality before.
- Module 3 / IND CMC sections
- Comparability & specifications strategy
- Process characterization summaries
- FDA Type C / pre-BLA CMC briefing support
Pre-Submission (Q-Sub) package
FDA CDRH meeting prep with a defensible pathway position. Get the right questions on the agenda before you commit to a 510(k), De Novo, or PMA.
- Q-Sub request letter and meeting agenda
- Briefing document with predicate analysis
- Question framing & FDA-style draft answers
- Mock meeting & coaching session
510(k), De Novo, PMA prep
Marketing application packages built around the right predicate strategy and clinical evidence framing. Whether you're filing a Traditional 510(k), De Novo, or PMA.
- Predicate device benchmarking
- Performance & clinical evidence strategy
- Submission narrative and labeling
- FDA-formatted submission package
Clinical Evaluation Reports (CER)
EU MDR/IVDR-compliant CERs and FDA-supportive clinical evaluations. Comprehensive literature search, evidence synthesis, and benefit-risk determination.
- Literature search with PRISMA flow
- Evidence summary tables
- Equivalent device analysis
- Benefit-risk synthesis & full CER document
How an engagement runs
From first call to delivered package. Scope-dependent, typically 2 to 14 weeks.
30-minute scoping call
We map your program, milestones, and the FDA interactions ahead. No NDA needed.
Fixed-fee SOW in 24h
One-page statement of work: deliverables, timeline, price, and proposed staffing.
Weekly drafts, not silence
Shared workspace with the engagement team. Working drafts every week. No big-bang reveal at the end.
Delivery & 30-day support
Final package, source files, and 30 days of revision support included by default.
Have a milestone in the next 90 days?
Send a short note about your program. You'll get a scoped proposal back within one business day, with timeline, fee, and proposed staffing.
Confidential. The first scoping conversation doesn't require an NDA. We execute one before any program-specific materials are shared.