An AI workspace built for regulatory work
Workbench works alongside RA teams to analyse requirements, plan submissions and draft documents. It pulls in your licence context, authority requirements, source documents and prior decisions, so every output can be traced back to its sources and reviewed.
Plan, analyse and draft in one place
Everything runs against your own licence data and sources, and every output is traceable.
Plan the Type IB variation to add a 40 mg strength to our DCP product across DE, FR and IE
Regunaut08:50 PMPlan regulatory submission strategy for a Type IB variation to add a new 40 mg strength for a decentralized procedure (DCP) medicinal product in Germany, France, and Ireland. - targeting cmdh, eur_lex, hma_mri, edqm_standard_terms
Do notplan this as a Type IB variation: adding a new 40 mg strength to an existing DCP medicinal product should normally be planned as an extension / line-extension application, not a Type IB variation, because it adds a new strength of the product. Submit it through the MR/DC framework covering Germany, France and Ireland, with the existing RMS leading the procedure where possible.
Follow-up questions
Complex regulatory projects live across documents, tools and people
Planning a submission, interpreting a requirement or drafting a response means pulling context from guidance, licences, past decisions and colleagues. General-purpose AI doesn't know your portfolio, and doing it by hand is slow and hard to keep consistent across a lean team.
From a question to grounded, reviewable output
Describe the task
Ask a regulatory question or set a goal: a variation to plan, a requirement to interpret, a document to draft.
Workbench traces the context
It pulls the relevant licences, authority requirements, source documents and prior decisions, then analyses, plans and drafts against them.
Review grounded results
Every output is traceable to its sources, so you can check the reasoning before you act on it.
Analysis and drafting that know your portfolio
Grounded answers
Responses draw on your licence data and authority requirements rather than the model's general knowledge.
Plan & draft
Turn a goal into a structured plan, checklist or first-draft document you can refine, instead of a blank page.
Source traceability
Every claim and step links back to the licences, documents and decisions behind it, so outputs stay reviewable.
Connected to the platform
Works with Atlas and Alerts, so portfolio context and live regulatory changes feed directly into the work.
Built for the way regulatory work actually happens
Knows your portfolio
Grounded in your licences and obligations, so its output reflects your products rather than generic templates.
Always reviewable
Traceable sources mean a human can verify every output, which is non-negotiable in regulatory work.
Leverage for a lean team
It takes on the heavy analysis and drafting so a small team can cover more ground, faster.
Regulatory execution that used to need a department — run by a team of a few.
Move complex regulatory work faster
See how Workbench plans and drafts regulatory work, grounded in your own data.