Redlineo

Pharma & life sciences · EU / UK

The clean copy and the track-changes copy, from one compare.

EMA procedures — variations, renewals — expect revised product information (SmPC, labelling, package leaflet) submitted as both a clean and a track-changes version. The revised document you already have is the clean copy. Regulatory-affairs teams mostly produce the other one by hand in Word. Drop the previous and revised versions here instead: the track-changes copy is generated, verified, and carries its own proof.

SmPC · §4.2 10 mg once daily 5 mg once daily — tracked · verified

Same primitive, regulatory-affairs vocabulary

The submission, the tables.

  • The submission

    Product information as clean + track changes

    Among the variation application documents, the revised SmPC, labelling and package leaflet travel in two forms: the clean version and the annotated version showing the changes — the "clean and annotated" pair every EMA tracked changes submission needs. Compare the previously approved version against the revised one and the marked copy comes out as real Word tracked changes — or as baked strikeout/underline colors, viewer-independent and ready for PDF.

  • The tables

    Dosing & stability tables

    The spreadsheet analogue of a rate page. Drop the two versions of a dosing or stability workbook: the print areas become a paged Word redline, or a colored Excel review copy — rows and columns re-synchronize, so an inserted row does not cascade into a wall of false deltas.

Why it fits regulatory affairs

Proof that speaks the data-integrity language.

  • ✔Verified redlines. Accept-all reproduces the revised document; reject-all restores the previous one — re-checked and stamped ✔ on every run. The marked copy provably matches the clean copy.
  • ✔The certificate. SHA-256 fingerprints of the exact input versions, recomputable by anyone — the marked copy is tied to the documents it came from.
  • ✔Tamper-evident manifest. Drop a stored output on the Verify page years later; it proves it is the real, unmodified artifact — audit-trail evidence without a database.
  • ✔Any language. The comparison is content-based, not language-specific — a German or French SmPC diffs the same as an English one.
  • ✔Headers and footers included. Changes in running headers and footers are redlined too — not silently skipped.
  • ✔Self-hosted, nothing stored. Pure Java on your own servers; each request computed and forgotten. Unapproved product information never leaves your infrastructure.
Also fits Health Canada follows a similar practice for product monograph revisions — a clean copy plus a copy showing the changes. The same compare produces both deliverables' marked half, wherever the convention applies.
Configured for your conventions Metadata extraction, assertions and profiles are editable application.yaml — mapping the tool to your document-control conventions is configuration, not custom development. And it is deterministic: the same two versions always produce the same marked copy — an audit property, not a limitation.
Illustration · SmPC, §4.2 Posology and method of administration The recommended starting dose is 10 mg once daily 5 mg once daily for the first two weeks, then 10 mg once daily, taken with food. No dose adjustment is required in mild hepatic impairment.
— 41 unchanged paragraphs omitted —

Next

One compare, both copies covered.

See how verification and the certificate work in the feature detail. US-facing life sciences? See FDA labeling & protocol amendments. Related: standards bodies, healthcare payer contracts.

Ask for a walkthrough Security & compliance
  • SmPC tracked changes
  • EMA tracked changes submission
  • EMA variation product information
  • variation application documents
  • package leaflet comparison
  • clean and annotated version
  • clean and track changes copy
  • product information redline
  • Health Canada product monograph comparison
  • regulatory affairs document comparison