Generated by Yoast SEO v26.0, this is an llms.txt file, meant for consumption by LLMs.

The XML sitemap of this website can by found by following [this link](https://somerville-partners.com/sitemap_index.xml).

# Somerville Partners: We are a European Regulatory Affairs Consultancy

> We are a European Regulatory Affairs consultancy providing regulatory expertise to pharma \& biotech companies developing innovative medicines\.

## Pages
- [Newsletter Signup](https://somerville-partners.com/newsletter-signup/)
- [Glossary of Regulatory Deliverables](https://somerville-partners.com/glossary-regulatory-deliverables/)
- [Terms and Conditions of Use](https://somerville-partners.com/terms-and-conditions-of-use/)
- [Services](https://somerville-partners.com/services/)
- [Our Team](https://somerville-partners.com/our-team/)

## Posts
- [Novel medicines approved in 2024: A review  ](https://somerville-partners.com/novel-medicines-approved-in-2024-a-review/): The European Medicines Agency \(EMA\), the Food and Drug Administration \(FDA\) and the Medicines and Healthcare Products Regulatory Agency \(MHRA\) approved 53 novel medicines in 2024; with 53% of these products being first in class\.
- [What is the MHRA's Innovative Licensing and Access Pathway \(ILAP\)?](https://somerville-partners.com/an-overview-of-the-medicines-and-healthcare-products-agency-mhra-innovative-licensing-and-access-pathway-ilap/): The ILAP pathway is available to global commercial and non\-commercial medicine developers\. ILAP supports organisations developing new chemical substances and biologics, and new indications\.
- [What is the Pre\-CTA Scientific Advice Pilot Programme?](https://somerville-partners.com/what-is-the-pre-cta-scientific-advice-pilot-programme/): In June 2024, the Accelerating Clinical Trials in the EU \(ACT EU\) initiative rolled out a new pilot program to enhance the quality of applications for clinical trial authorisation \(CTAs\)\.
- [MHRA ILAP Relaunch 2025: Innovation Passport, Eligibility \& Accelerated Access](https://somerville-partners.com/the-medicines-and-healthcare-products-agency-mhra-has-relaunched-its-innovative-licensing-and-access-pathway-ilap/): The Innovative Licensing and Access Pathway \(ILAP\) is evolving to bring transformative medicines to NHS patients faster\. Relaunching in March 2025, the updated pathway will feature streamlined processes, selective entry criteria, and stronger collaboration with the NHS to address unmet needs\. 
- [The EMA’s new fees: What does the new fee regulation mean for medicine developers?](https://somerville-partners.com/the-emas-new-fees-what-does-the-new-fee-regulation-mean-for-medicine-developers/): The fees payable to the EMA will follow the current legal framework until December 31st, 2024\. Then, as of January 1st, 2025, the new fee regulation \(EU 2024/568\) will be implemented\. 

## Case Studies
- [Sample Case Study](https://somerville-partners.com/case-study/sample-case-study/)

## Resources
- [The EMA’s 2024 Medicine Approvals: Key Takeaways and Trends](https://somerville-partners.com/resources/the-emas-2024-medicine-approvals-key-takeaways-and-trends/): All of the CHMP evaluations for 2024 have now been released and we are pleased to present our digest of the 2024 approvals\.
- [The EMA’s 2024 Medicine Approvals: Key Takeaways and Trends](https://somerville-partners.com/resources/the-emas-2024-medicine-approvals-key-takeaways-trends-786345/)
- [How to get a medicine approved in Europe](https://somerville-partners.com/resources/marketing-authorisation-applications-in-a-nutshell/)
- [How to get a medicine approved in Europe](https://somerville-partners.com/resources/marketing-applications/): Submitting an MAA is a significant undertaking\. Planning an MAA should start 2–3 years before submission to ensure adequate time to navigate the regulatory milestones and assemble all the dossier components\.

- [Approval Deep Dive \- Cejemly \(sugemalimab\)](https://somerville-partners.com/resources/approval-deep-dive-cejemly-sugemalimab/): Access our deep dive into this approval – in a useful, downloadable PDF format\.

## Categories
- [European Medicines Agency](https://somerville-partners.com/category/european-medicines-agency/)
- [Regulatory Affairs](https://somerville-partners.com/category/regulatory-affairs/)
- [Marketing Authorisation Application](https://somerville-partners.com/category/marketing-authorisation-application/)
- [Executive Summary](https://somerville-partners.com/category/executive-summary/)
- [Scientific Advice](https://somerville-partners.com/category/scientific-advice/)

## Tags
- [drug development](https://somerville-partners.com/tag/drug-development/)
- [ATMP](https://somerville-partners.com/tag/atmp/)
- [SMEs](https://somerville-partners.com/tag/smes/)
- [FDA](https://somerville-partners.com/tag/fda/)
- [Oncology](https://somerville-partners.com/tag/oncology/)

## Type
- [module](https://somerville-partners.com/layout_type/module/)
- [layout](https://somerville-partners.com/layout_type/layout/)
- [section](https://somerville-partners.com/layout_type/section/)
- [row](https://somerville-partners.com/layout_type/row/)

## Module Width
- [regular](https://somerville-partners.com/module_width/regular/)

## Scope
- [not\_global](https://somerville-partners.com/scope/not_global/)
- [global](https://somerville-partners.com/scope/global/)

## Resources categories
- [hidden](https://somerville-partners.com/resources_category/hidden/)
- [Guides](https://somerville-partners.com/resources_category/guides/)
- [Webinars](https://somerville-partners.com/resources_category/webinars/)
- [Approval Deep Dive](https://somerville-partners.com/resources_category/approval-deep-dive/)
- [Whitepaper](https://somerville-partners.com/resources_category/whitepaper/)