A photography of Confident business male and female team discussing a project, A male siting on chair have laptop in front

UK & EU Special Relationship 

In light of the significant consequences brought about by Brexit, our comprehensive European expertise and extensive footprint ensure effortless access to both the EU and UK markets. With a profound understanding of the expectations set forth by the Medicines and Healthcare products Regulatory Agency (MHRA) and the intricacies of Notified Bodies, we are poised to provide unparalleled support across various needs and scenarios. 

Support for UK-Based Companies 

Product Approvals: We specialise in guiding UK-based companies through the process of obtaining product approvals in the UK. Our team’s in-depth knowledge of MHRA requirements means that we can streamline the approval process, ensuring that your products meet all necessary standards and regulations. 

Market Expansion: We assist UK companies looking to expand their market reach into Europe, navigating the post-Brexit regulatory landscape to maintain and grow your business presence across the continent. 

Support for European Companies 

Continued Business Operations: We provide robust support for European companies aiming to continue their business operations within the UK. Our expertise in UK regulatory requirements ensures a smooth transition and ongoing compliance, allowing your business to thrive despite the new regulatory environment. 

Regulatory Compliance: With the changing landscape, we help European companies stay abreast of and compliant with UK-specific regulations, ensuring uninterrupted operations and market access. 

Support for Non-European Companies 

UK Market Entry: We offer tailored strategies for non-European companies seeking to enter the UK market. From regulatory approvals to market distribution, our team provides end-to-end support to ensure a successful entry and sustainable growth within the UK. 

EU Market Access: For non-European companies targeting the EU market, we facilitate entry through both centralised procedures (such as EMA approval) and CE Marking, as well as decentralised procedures where applicable. Our expertise ensures that your products meet the stringent requirements of European regulations. 

Leveraging Our European Network 

Thanks to our extensive network of Subject Matter Experts located in various European countries, we can offer localised support and insights that are crucial for navigating complex regulatory environments. Our services include: 

  • For UK-Based Companies: Assistance in maintaining and expanding business operations across Europe, leveraging our knowledge of local regulations and market conditions. 
  • For European and Non-European Companies: Continuous monitoring and compliance support with local regulations in various European countries, ensuring that your business remains compliant and competitive. 

Special Focus on French Healthcare Authorities (ANSM) 

We pride ourselves on our particularly strong capability to engage with French healthcare authorities (ANSM). Our team is adept at handling requests and ensuring compliance with French regulators, providing a crucial advantage for businesses operating in or entering the French market. 

Connect with Us 

Are you interested in having an initial conversation to explore how we can support your business needs, whether in French or English? Please do not hesitate to reach out! We are here to help you navigate the complexities of the UK and EU markets with confidence and ease. 

Contact us today to learn more about our services and how we can help your business thrive in the evolving regulatory landscape.