Straight answers about REGARA^™.

REGARA is an AI-native operating system for life sciences regulatory affairs. It combines a daily-indexed regulatory knowledge graph — covering FDA, EMA, PMDA, NMPA, MHRA, Health Canada, TGA, and ANVISA — with AI agents purpose-built for the precise, auditable, evidence-driven nature of regulatory work. The platform drafts submissions, surfaces precedent, and keeps every claim source-anchored.

REGARA is built for regulatory affairs leaders, quality and compliance teams, and clinical and medical affairs professionals at life sciences companies — including medical device, pharmaceutical, biologics, and in-vitro-diagnostic sponsors. It serves both established multinationals and emerging innovators.

REGARA supports the major submission pathways across medical device (510(k), De Novo, PMA, Q-sub), pharmaceutical (IND, NDA, ANDA), biologics (BLA 351(a) and 351(k), biosimilars, cell and gene therapy), and IVD (IVDR technical documentation, LDT). The platform configures each submission against the agency, classification, and pathway you select.

Augmented intelligence means AI that amplifies a human expert rather than replacing them. In REGARA, that means AI agents read, draft, and surface precedent — and a regulatory professional reviews, edits, and approves. Every output is traceable to its source and inspector-defensible, and the human regulator remains the decision-maker.

REGARA is being built for HIPAA compliance; our HIPAA program and BAA availability are in progress. The platform already includes automatic PHI detection and redaction at ingest, with detection results logged in the audit trail.

REGARA's ISO 27001 certification (information security management) is in progress. Our compliance roadmap and Statement of Applicability are available under NDA.

A 510(k) is a U.S. FDA premarket notification that demonstrates a new medical device is substantially equivalent to a legally marketed predicate device. REGARA scaffolds every required section of a 510(k), drafts substantial equivalence discussions, and surfaces predicates by indication, technology, and SE proximity — not just keyword.

A Premarket Approval (PMA) is the FDA's most stringent device-marketing application, typically required for Class III medical devices supporting life or preventing significant impairment. REGARA supports PMA strategy, briefing-book and panel-prep authoring, and clinical-narrative drafting with version-locked evidence.

Traditional consulting depends on the institutional memory of senior consultants and the time it takes them to read, research, and draft. REGARA delivers in minutes what legacy approaches deliver in weeks or months — and improves with every submission, because the institutional knowledge accretes to the platform rather than walking out the door when a consultant leaves.

No. REGARA augments regulatory affairs professionals. AI handles volume — reading guidance, surfacing precedent, scaffolding sections, drafting first passes. The regulatory professional handles judgment — strategy, review, agency negotiation, and final approval. REGARA does not submit to agencies; a human reviewer always approves, with the action logged in the audit trail.

REGARA's regulatory knowledge graph spans FDA (United States), EMA (European Union), PMDA (Japan), NMPA (China), MHRA (United Kingdom), Health Canada, TGA (Australia), and ANVISA (Brazil) — re-indexed daily.

REGARA users have reported a 67% median reduction in first-draft authoring time, with 3.2× more predicates surfaced per search than keyword-based approaches. Total cycle-time savings depend on the submission type and customer workflow, and are typically measured in weeks to months.

Yes. Every generation is reproducible from its inputs and the model state at the time it was produced. Every cited document is hash-anchored. Outputs that can't be anchored to a source are flagged, not surfaced. The audit trail is 21 CFR Part 11-aligned, capturing every prompt, edit, citation, and approval.

Request a 30-minute working session at regara.ai/contact or by emailing info@regara.ai. A regulatory strategist on the REGARA team will be in touch — no pitch deck, no sales engineer.