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REGLENS / REGULATORY INTELLIGENCE · ENFORCEMENT · DOCUMENTS

Find the basis.
Build a better draft.

Move from a regulatory question to a sourced answer, a structured draft, or a reviewed proposal. Your experts decide what applies.

Discuss your workflow ↗Explore the controls ↗

Explore in a tailored demo · See the sources, review steps, and records

THE REGLENS FAMILY / START WITH YOUR WORKFLOW

Research, drafting, review, Cite, Enforcements, and Agents can run independently. Explore one standalone tool or combine them around your workflow. Confirm packaging and setup in your evaluation.

REGLENS / FROM QUESTION TO REVIEWED DRAFT

Find the basis.
Build on it with care.

Research FDA, ICH, EU GMP, MHRA, PMDA (Japan), Health Canada, and NIST sources alongside your own SOPs. Your experts bring the regulatory context to each decision.

REGULATORY RESEARCH

An answer you can check.

Ask across FDA, ICH, EU GMP, MHRA, PMDA, Health Canada, and NIST sources alongside your own SOPs. Each statement in the answer is cited to the section it came from.

  • Open the cited section beside the answer.
  • See regulation and internal procedure cited separately.

Choose the supporting passages and assess their relevance to your question.

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ILLUSTRATION / CITED ANSWERIllustrative · fictional data
  1. Ask
  2. Cited answer
  3. Open the section
A batch failed its specification. What must the investigation cover?

The failure must be thoroughly investigated, extended to other batches that may be affected, and recorded with its conclusions and follow-up. Your quality manual is cited beside it as internal policy.

21 CFR 211.192 · ACME-QM-001 §5.0Regulation and internal document cited separately · Acme Biologics is fictional
Open each cited section before relying on the answer.
RegLens Ask: an answer on batch release records cited to 21 CFR 211.188 and EU GMP Part II, with the cited section open beside it and the supporting passage highlightedPRODUCT SCREENSHOT
RegLens Ask: an answer on batch release records cited to 21 CFR 211.188 and EU GMP Part II, with the cited section open beside it and the supporting passage highlighted · Product screenshot.
RegLens Generate: the section plan for a user requirements specification, where the author chooses, orders and adds the sections the AI will writePRODUCT SCREENSHOT
RegLens Generate: the section plan for a user requirements specification, where the author chooses, orders and adds the sections the AI will write · Product screenshot.
RegLens Review report on a draft deviation management SOP: ten findings graded critical, major and minor, each citing the requirement behind it
RegLens Review report on a draft deviation management SOP: ten findings graded critical, major and minor, each citing the requirement behind it · Product screenshot with fictional Acme Biologics demo data.
RegLens Enforcement Intelligence: recent FDA warning letters with the sections each one cites, and a letter open beside the listPRODUCT SCREENSHOT
RegLens Enforcement Intelligence: recent FDA warning letters with the sections each one cites, and a letter open beside the list · Product screenshot of published FDA enforcement records.
RegLens Enforcement Intelligence metrics: FDA warning letters by cited 21 CFR Part 211 section, and by yearPRODUCT SCREENSHOT
RegLens Enforcement Intelligence metrics: FDA warning letters by cited 21 CFR Part 211 section, and by year · Product screenshot of published FDA enforcement records.
RegLens Enforcement Intelligence metrics: FDA warning letters by site country and by year
RegLens Enforcement Intelligence metrics: FDA warning letters by site country and by year · Product screenshot of published FDA enforcement records.