PMSA Fall 2026Princeton, NJ · Oct 26–27. One talk and two posters: agentic dossier authoring and KOL intelligence.Meet the team
Regulatory, Access & Content

Faster dossiers and content. Clearer access decisions.

Draft from approved evidence, trace claims to their sources, and understand how payers make decisions.

Impact
~4 wk → 3 dper AMNOG Module 4 section
80%less manual payer monitoring
What we provide

Separate solutions, one shared aim

Less agency spend, shorter cycles, and experts who review instead of drafting from a blank page.

Payer & access intelligence

80%less manual monitoring
  • Payer intelligenceWhat payers and competitors decided, in a cited one-pager
  • Effective access scoreEach plan rated on real approval behaviour, not policy text
  • Measured access impactThe true effect of a formulary change, against matched plans
  • Contract & rebate scenariosThe volume and net revenue effect of an offer, in minutes
  • Prior authorisation insightsWhat actually gets approved at each plan, and pull-through gaps

Clinical & regulatory writing

Weeks → daysto a cited first draft
  • Clinical study report summariesDrafted from statistics tables, every number checked
  • Protocol draftingDrafts from templates and compares eligibility with similar trials
  • Plain-language summariesLay summaries of trial results, fact-checked
  • Health-authority responsesAnswers to regulator questions, drafted with citations

Safety & medical writing

  • Safety report narrativesPeriodic safety report narrative sections from line listings
  • Adverse-event case narrativesCase narratives with every date and dose checked
  • Medical information lettersResponse letters drafted from the evidence base
  • Literature review agentScreens abstracts and extracts data with sources
Case study · Market access

Agent-assisted AMNOG dossier authoring

The challenge

A typical AMNOG dossier costs €270–450k in agency fees and internal time, takes 3–5 months of senior HEOR time and is rebuilt for every country.

What we did

Agents learn each market's template from a past dossier, draft clinical value sections, evidence tables and statistical outputs, and check every number before experts review.

The results
~85–90%lower cost per dossier
~90%less time per Module 4 section
~70%complete, cited first draft in hours

Industry cost range shown for context; results are relative to the client's previous process.

Payer affairs80%

less time on manual payer and competitor monitoring, with every answer cited.

Global dossiers~85%

lower cost per global reimbursement dossier.

Inside the solution · Dossier Authoring

See the dossier workflow.

A few views of the authoring process, from cited drafting to evidence traceability. These screens illustrate the HTA dossier solution above.

Dossier Authoring workspace with a cited clinical review draft and AI copilot
Cited draft and AI copilot
Dossier Authoring source traceability screen
Source traceability
Dossier template blueprint screen
Template blueprint
Explore all Dossier Authoring screens

Explore the technology behind these solutions

Technology overview

Tell us the decision you want to make faster.

Book a walkthrough