Categories

REGARA™ across the medical product landscape.

Built for the three categories regulators evaluate differently — and configured for the standards, agencies, and submission pathways that govern each.

01
Medical Device

From Class I through PMA, with predicate intelligence and substantial equivalence drafting that holds up under review.

 02
Pharmaceutical

IND, NDA, ANDA — across FDA, EMA, and PMDA. Module 2 summaries, labeling, and agency-question responses from a single source of truth.

 03
Biologics

BLA, biosimilars, and advanced therapies. CMC, comparability, and the unique regulatory ground that biologics occupy.
01 · Medical Device

510(k), De Novo, PMA — and every Q-sub between them.

From Class I labeling to PMA panel preparation. Substantial equivalence drafting that holds under review, with predicate intelligence that goes deeper than keyword search.

  • 01
    Predicate intelligence

    Search by indication, technology, and substantial-equivalence proximity. Surface predicates a reviewer would actually accept.

  • 02
    Pre-submission strategy

    Q-sub drafting with precedent from prior responses on similar programs. Know the questions before they're asked.

  • 03
    Substantial equivalence

    Side-by-side comparison drafting with traceable claims and consensus-standard alignment.

  • 04
    PMA panel preparation

    Briefing books, advisory committee prep, and clinical narrative drafting with version-locked evidence.

  • 05
    SaMD & AI/ML

    Predetermined Change Control Plans, GMLP, and the cybersecurity expectations of the current FDA guidance (February 2026) — out of the box.

  • 06
    IVD & companion diagnostics

    IVDR technical documentation, performance evaluation reports, and the FDA's evolving LDT framework — handled.

Configured for
FDA CDRH510(k) · De Novo · PMA EU MDRNotified body PMDAShonin · Ninsho · Todokede UK MHRAUKCA · UKNI Health CanadaMDL · MDEL
  • 01
    Module 2 summaries

    Clinical and nonclinical overviews drafted from primary sources, with citations to the underlying study reports.

  • 02
    Response to agency questions

    Days, not weeks. REGARA™ assembles candidate responses with evidence; your reviewers approve, edit, or reject.

  • 03
    Labeling negotiation

    Track every label change across cycles, with precedent from similar approved labels and review-division patterns.

  • 04
    Periodic safety reporting

    PSUR / PADER / DSUR drafting with versioned safety-database integration and signal context.

  • 05
    Generic & ANDA pathways

    Bioequivalence, Q1/Q2 strategy, and labeling-carve-out support across FDA and EMA generic pathways.

  • 06
    Post-marketing commitments

    PMC and PMR tracking, with the artifacts each commitment requires drafted on schedule.

02 · Pharmaceutical

IND through NDA, across FDA, EMA, and PMDA.

Built for sponsors filing in parallel across regions. Module 2 summary drafting, response-to-questions, labeling, and post-marketing — every artifact source-anchored.

Configured for
FDA CDERIND · NDA · ANDA EMA CHMPCentralised CMDhDCP / MRP PMDAJ-NDA · CTN NMPACDE ANVISA · TGALATAM · APAC
03 · Biologics

BLA, biosimilars, and advanced therapies.

Biologics occupy regulatory ground that doesn't quite belong to devices or to small molecules. REGARA™ is configured for the standards, comparability expectations, and review-division patterns that make biologics their own discipline.

  • 01
    BLA authoring

    351(a) and 351(k) BLA drafting with CMC, nonclinical, and clinical modules cross-referenced and source-anchored.

  • 02
    Comparability protocols

    Pre- and post-approval comparability — analytical, nonclinical, and clinical — with precedent from approved programs.

  • 03
    Biosimilar pathways

    351(k), similarity rationale, and totality-of-evidence narrative. The story your biosimilar has to tell, written to FDA expectations.

  • 04
    Cell & gene therapy

    RMAT, INTERACT, and the unique CMC challenges of advanced therapies — with the FDA OTP (formerly OTAT) review patterns built in.

  • 05
    Manufacturing changes

    Prior approval supplements, CBE-30, and the analytical comparability that supports each.

  • 06
    Pharmacovigilance

    Biologic-specific PV: immunogenicity reporting, traceability, and the post-market obligations of long half-life products.

Configured for
FDA CBERBLA · IND · RMAT FDA OTPCell & gene EMA CATATMP PMDARegenerative Med Act
See your category in REGARA™

Bring a submission. We'll show you the difference.

A 60-minute working session on a project of your choosing. Under NDA, on isolated infrastructure, with your team's reviewers in the room.

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