EXPERTISE & MARKETS
UK, EU & international regulatory experience
Experience focused on the requirements that affect the authorisation and lifecycle management of human medicinal products.
MARKETS & CAPABILITIES
Understanding the regulatory environment
United Kingdom
Support relating to MHRA regulatory requirements, UK marketing authorisation procedures, dossier documentation, product information and post-authorisation activities.
European Union
Support for EU and Member State regulatory requirements, including centralised, decentralised, mutual recognition and national procedures, as applicable to the relevant product and project.
Selected international markets
Additional international exposure can support the early identification of documentation and procedural differences. Coverage outside the UK and EU is assessed and agreed on a project-by-project basis.
Human medicinal products
Services address regulatory activities for human medicinal products across therapeutic areas and product categories, including generic and other products, depending on the available evidence and required expertise.
Regulatory documentation
Practical areas of expertise include CTD/eCTD dossiers, marketing authorisation applications, procedural responses, product information, variations, renewals, transfers and due diligence.
DISCUSS A PROJECT
Need specialist regulatory affairs support?
Get in touch to discuss the regulatory scope and documentation requirements for your project.