Six modules. One platform. Every step of the regulatory lifecycle.
From the first strategy memo to the last post-market report — REGARA™ is the connective tissue your regulatory team has been writing in spreadsheets.
Pathway analysis, precedent-driven strategy, and Q-sub planning.
02 · DesignProtocol authoring grounded in indication, precedent, and statistical rigor.
03 · AuthorEvery section, every agency — drafted against live guidance.
04 · ReportPeriodic reports, post-market surveillance, and agency correspondence.
05 · SimulateReviewer simulations, deficiency-letter prediction, and panel rehearsal.
06 · StoreSource-anchored evidence, claims, and submission history — versioned forever.
- 01Pathway analysis
Classification, submission type, predicate proximity, and global registration sequencing — modeled with the agency's own decision logic.
- 02Q-sub & pre-IND planning
Draft pre-submission packages with precedent from prior agency responses on similar programs. Know the questions before they're asked.
- 03Global registration mapping
FDA, EMA, PMDA, NMPA, MHRA, Health Canada, TGA — one strategy view, regional differences flagged.
- 04Risk-benefit narrative
The story your submission has to tell, drafted from your evidence and the standard your reviewer will weigh it against.
- 01Indication-grounded protocols
Protocol authoring that starts from the indication and the standard — not from a generic template.
- 02Statistical rigor
Powering, endpoint selection, and sensitivity analyses with precedent from approved programs in the same therapeutic area.
- 03Investigator brochure
IB drafting and updates, with nonclinical and clinical sections traced to the underlying study reports.
- 04Amendment management
Protocol amendments versioned, redlined, and routed for IRB submission with the rationale captured in the audit trail.
- 01Substantial equivalence
Side-by-side comparison drafting with traceable claims and consensus-standard alignment that holds up under reviewer scrutiny.
- 02Module 2 summaries
Clinical and nonclinical overviews drafted from primary sources, with citations to the underlying study reports.
- 03eCTD / eSTAR / IMDRF ToC export
Submission-ready packaging for FDA, EMA, PMDA, and Health Canada. No re-formatting at the finish line.
- 04Multi-region parallel filing
One dossier, regional variants generated and synchronized. Differences flagged, never silently propagated.
- 01Periodic safety reports
PSUR, PADER, DSUR drafting with versioned safety-database integration and signal context.
- 02Post-market surveillance
MDR, MIR, and FSCA drafting with linkage to complaints, CAPA, and the underlying device-history record.
- 03Annual / periodic reports
FDA annual reports, EMA renewal applications, and IDE annual reports — drafted from the source of truth.
- 04Response to agency questions
Days, not weeks. REGARA™ assembles candidate responses with evidence; your reviewers approve, edit, or reject.
- 01Reviewer simulation
Run your draft against a panel of simulated reviewers trained on agency decision patterns for your device class and therapeutic area.
- 02Deficiency-letter prediction
The five most likely agency questions, ranked, with the evidence gap that drives each.
- 03Advisory committee rehearsal
PMA panel prep with simulated committee questions, drawn from prior panels in the same review division.
- 04Label negotiation modeling
Model the label your evidence supports — and the label your reviewer is likely to accept. The delta is where you negotiate.
- 01Evidence vault
Every study report, test record, and source document — versioned, hash-anchored, retrievable by content.
- 02Claims library
Marketing claims, technical claims, performance claims — each anchored to its evidence, reusable across submissions and labeling.
- 03Submission history
Every version of every submission you've filed. Reproduce the exact draft you submitted on any date, with the model state pinned.
- 0421 CFR Part 11 ready
Audit trail, electronic signatures, and validation documentation aligned with FDA Part 11. Inspection-ready by default.
Built for every route to market.
Whichever pathway your device or product takes, REGARA drafts against current guidance and keeps every claim traceable. Explore the pathway you're filing.
Draft a Premarket Notification, find substantially equivalent predicates, and defend substantial equivalence.
FDA · DeviceBuild the special-controls case for a novel low-to-moderate-risk device with no valid predicate.
FDA · DeviceAssemble a modular Premarket Approval with clinical, non-clinical, and manufacturing evidence.
EU · CE MarkingCompile Annex II/III technical documentation and GSPR conformity for your notified body.
CapabilityRank substantially equivalent predicates by indication, technology, and SE proximity.
CapabilityA daily-indexed atlas of FDA, EMA, and PMDA guidance mapped to your submission.
We'll walk it with you, module by module.
Tell us your pathway, your timeline, and your blockers. A 30-minute call with a regulatory strategist — no pitch deck, no sales engineer.