Compliance Studio Resource Center

AI can produce a regulatory answer in seconds. It can summarise a regulation, suggest a classification, create a market-entry pathway or draft a checklist. But a useful answer is not necessarily a defensible one. Can you explain which product, market, regulatory assumptions and source material the answer was based on? Can a colleague review it? Can the organisation reassess it when the regulation, product or intended market changes? For Regulatory Affairs, those questions mat

Regulatory work is rarely a single task. A product may already be established in one market while the team is assessing entry into another. Existing applicability decisions may be spread across spreadsheets, documents and individual expertise. New developments may affect decisions that were made months or years ago. Compliance Studio brings these activities together around one central construct: the Regulatory Position. A Regulatory Position is the documented regulatory cont

There is a comforting assumption behind regulatory monitoring: if something important changes, we will find it. For a long time, that was a reasonable assumption. Regulatory Affairs knew its authorities, its legislation and the sources worth following. A medical device team watched medical device regulation. Pharma watched the medicines authorities. Global teams followed the major jurisdictions and local teams kept an eye on what happened closer to home. The challenge was ke

Regulatory work rarely happens in isolation. Positions need to be reviewed, questions need input from colleagues, and decisions often involve people across different roles and functions. With the new collaboration features in Compliance Studio, you can now bring those people directly into your project. Invite your whole team — for free Compliance Studio now lets you invite an unlimited number of team members to your project as Editors or Viewers. Editors can actively contribu