Solutions · For Regulatory Affairs

The new law, turned into your product-specific to-do list

New legislation rarely tells you what to do with your products. It states obligations and leaves the translation to you. Regunaut does that translation: it reads the requirement, maps it to your portfolio, and produces the concrete actions each MA needs.

Obligation-to-action

Legal language becomes assignable work

Rule → tasks
Article 118

Maintain a shortage-prevention plan for products with supply risk.

1Identify affected MAs
2Draft product checklist
3Assign country owners

Outcome

Product-specific action plan

Instead of a reading assignment, each obligation becomes scoped work against real products, owners, markets and evidence.

The problem

Reading a regulation and knowing what to do about it are two different jobs

The 2026 EU Pharma Package and its guidance run to hundreds of pages of obligations. Working out which ones touch your products, what each one requires and in what order, for every strength, market and procedure, is slow expert work that's easy to get wrong and hard to keep consistent.

How it works

From legal text to a plan you can execute

1

Point it at the obligation

Start from a regulation, guideline or a change Alerts surfaced: the source of the requirement.

2

It maps to your portfolio

Workbench interprets the obligation against your licences in Atlas, identifying exactly which MAs are in scope and why.

3

Get a product-specific to-do list

A concrete, ordered set of actions per product, with the reasoning and sources behind each, ready to assign and track.

Workbench scenario

Turn an obligation into product-specific work

Workbench interprets the rule, scopes your portfolio and drafts assignable actions.

Workbench
+ New Task
Solution scenario/Action plan

The new shortage-prevention obligation applies to Rx products. Which of our MAs are in scope and what should each product owner do?

Regunaut
Regunaut12:39
35.05s8 sources94% confidence1 warning
1 warning

Executive summary

This obligation should become three work packets rather than twelve separate projects. All 12 MAs are in scope, but the work is not the same everywhere.

DE, FR and IE need local template deltas. Four products need supply-risk evidence attached. The remaining five can move on the standard prevention-plan checklist.

The useful output is the translation layer: the rule becomes scoped owner tasks with market-specific notes, so RA does not have to run the same interpretation meeting for every product.

Action plan

Each recommendation carries its reasoning and a source trail, so the result can go straight to RA, BD or the product owner.

Work packets
Filter table...3 rows
ItemWorkbench readStatus
Scope packet12 MAs matched by Rx status, active substance, and market.Check
Local deltasDE, FR, and IE get country-specific owner tasks.Needs review
Standard pathFive products move on the prevention-plan checklist.Ready
12 scoped MAsDirective textAtlas licencesCountry templates
Why Regunaut

The hard translation, done once and grounded in your data

Consistent every time

The same rigorous mapping across every obligation and product, regardless of who reads the text first.

Built from your portfolio

Actions reflect your actual licences in Atlas, so the list is yours rather than a template.

Audit-ready

Traceable from action back to source, so you can show why each step was taken.

One careful reading of the law, applied consistently to every product.

Turn the next obligation into a plan

See how Regunaut converts new regulation into product-specific actions.

Book a 30-min walkthrough