Resources
Take a look at our regulatory resources, which explain essential details and offer advice on how and when to approach each project.
Subscribe to our monthly newsletter
The latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
Unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.
Pre-approval regulatory deliverables and how the new pharmaceutical legislation will affect medicine development
Rethinking cancer drug dosing: How Project Optimus is redefining oncology drug dose optimisation
This whitepaper examines the scientific and regulatory drivers behind Project Optimus and explores the practical implications for oncology developers.
How to future-proof your EU regulatory deliverables and the impact of the new pharmaceutical legislation on medicine development
EMA 2025 Medicine Approvals: Key Regulatory Trends for Pharmaceutical and Biotech Companies
Interesting Approval: Ordspono & Columvi
The EMA’s 2024 Medicine Approvals: Key Takeaways and Trends
How to get a medicine approved in Europe
Approval Deep Dive – Cejemly (sugemalimab)
Access our deep dive into this approval – in a useful, downloadable PDF format.
Approval Deep Dive – Winrevair (sotatercept)
Access our deep dive into this approval – in a useful, downloadable PDF format.
The Critical Role of Scientific Advice in the EU
Taking scientific advice during a development programme is imperative because being forewarned is forearmed.
Crafting Effective Scientific Advice Strategies in the EU
Applying for Orphan Designation
Agreeing a Paediatric Investigation Plan with the Paediatric Committee
This resource gives you advice on how and when to submit the PIP.
Taking scientific advice and protocol assistance (PRIME and ILAP)
Find out how to plan your scientific advice or protocol assistance, and what fee reductions are available.
Creating an Effective Regulatory Plan
