Case · Life Sciences

One approved statement. Every document, aligned.

Medical Affairs and Regulatory teams restate the same evidence across dossiers, study reports, HTA submissions and medical information responses. Cohesta turns that evidence into governed components — approved once, reused everywhere, kept in sync.

Teams
Medical Affairs, Regulatory Affairs, Medical Writing
Documents
Value dossiers, CSRs, HTA submissions, MI responses
Capabilities
Component Based Authoring, Sync changes, Update all
The challenge

Content drifts the moment it is copied.

The evidence is approved once. Then it is pasted, paraphrased and re-verified in every document that needs it.

01

Rewritten in every document

The same comparison, safety table or claim is rebuilt for each dossier, report and response — by different people, in different words.

02

Updates land in one place

When the evidence changes, the edit reaches one document and misses the rest. Contradictions surface in review — or with the regulator.

03

Reviewers re-check what was approved

Without lineage back to a controlled source, every copy is verified again. Review time grows with each new document.

The industry view

Authoring teams often add large volumes of unnecessary information to regulatory documents, leading to multiple manual reviews, revisions, and the risk of contradiction across related documents.

John April, Eli Lilly and Company · Inger Ødum Nielsen, Novo NordiskApplied Clinical Trials, 2025

Regulatory reviewers save time during review by not having to re-read the same content over and over across many documents.

John April, Eli Lilly and Company · Inger Ødum Nielsen, Novo NordiskApplied Clinical Trials, 2025

Build state-of-the-art gen AI authoring platforms with reusable components that balance flexibility and precision for high-stakes documents.

McKinsey Life Sciences PracticeRewiring pharma’s regulatory submissions with AI, 2025
How Cohesta addresses it

Govern the component, not the copy.

Performance

What governed authoring is worth.

Industry benchmarks for AI-assisted, structured regulatory writing — the gains Cohesta is built to deliver.

40%

shorter end-to-end authoring cycle for clinical study reports in early gen-AI pilots.

McKinsey, 2025
56%

less first-draft CSR writing time at Merck — from 180 to 80 hours on an AI authoring platform.

Merck & McKinsey, 2025
50%

fewer errors in first drafts on the same platform.

Merck & McKinsey, 2025
Consistency

One version of the evidence

Every dossier, report and response carries the current approved component.

Review

Verify once, not per document

Reviewers approve a change a single time; placements inherit it.

Audit

Lineage by default

Source evidence → component → every placement, traceable end to end.

See it on your content

Approve once. Reuse everywhere.

Bring one dossier and its source evidence. We’ll show the component, the redline and the update across every document.

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