Regulatory solutions for pharma teams
Seven workflows for the regulatory affairs teams who keep licences compliant and the business development teams who decide where to go next. Each one shows which Regunaut product does which step.
Regulatory affairs and business development
Regulatory affairs teams carry the obligations that come with every marketing authorisation: authority updates to assess, renewals, variations and PSURs to schedule, and product information and artwork to keep aligned with what was approved. The regulatory affairs solutions connect those obligations to the products and markets they affect, and help turn them into a plan someone owns.
Business development teams need regulatory answers to make commercial calls: who holds which authorisations, where a product could be registered next, and when exclusivity ends for a reference product. The business development solutions build sourced, reviewable answers to those questions.
Each solution runs on the same Regunaut platform tools, and the changes in the new EU pharma package map onto them topic by topic.
For regulatory affairs
Portfolio impact monitoring
Connect authority updates with the products they affect
ExploreObligation-to-action
Turn requirements into a product-specific action plan
ExploreePI & labelling
Compare approved text and artwork; plan for ePI
ExploreRegulatory lifecycle planning
Plan renewals, variations and PSUR work
ExploreCommon questions about the solutions
What is a solution, compared with a platform tool?
A tool does one task: research, pricing, screening a name, checking artwork. A solution is a workflow a regulatory or business development team runs end to end, such as monitoring a portfolio for regulatory change or planning a market entry, with each step assigned to the tool that does it.
Which solutions are for regulatory affairs?
Portfolio monitoring, turning a new obligation into product-level actions, ePI and labelling review, and regulatory lifecycle planning for renewals, variations, fees and agency responses.
Which solutions are for business development?
Competitive intelligence from EPARs and public registers, market expansion planning from the licences you already hold, and loss-of-exclusivity timing for generic filing and launch dates.
How do the solutions relate to the EU pharma package?
The new directive and regulation change renewals, variations, PSURs, product information, exclusivity and shortage obligations. The EU pharma package hub explains each change, and the matching solution shows how to turn it into work on your own products.
Can we start with one workflow?
Yes. Most teams start with the workflow that costs them the most time, often portfolio monitoring or lifecycle planning, on their own products and markets, and add others later.
Bring us the workflow you want to fix
Book a 30-minute walkthrough and we will show how Regunaut handles it with your products and markets.