Founded in Cardiff, UK, in 1992 by Julian Baines MBE and led by Managing Director Jonathan Phillips since 1997, our company has grown into a leading regulatory compliance consultancy serving customers worldwide, including Canada, China, Denmark, England, France, Germany, India, Scotland, Sweden, the USA, and Wales.
We began with ISO 9001 and ISO 13485 consultancy and training, expanding to provide comprehensive support for CE and UKCA compliant quality management systems and technical files. Our services include both on-site and remote audits, guiding clients through the entire certification process.
Through our Belfast-based subsidiary, EU-UK Authorised Representative Ltd, we provide essential services under the new EU General Product Safety Regulation (EU) 2023/988 (GPSR). This strategic presence enables us to serve as an authorised representative for companies needing representation in both the EU and UK markets. Our GPSR services include guidance on mandatory accident reporting, product registration systems, recall procedures, and compliance with new requirements for product safety, risk assessment, and traceability systems.
We also provide specialised EU Authorised Representative services for medical devices and in vitro diagnostic medical devices under EU MDR 2017/745 and EU IVDR 2017/746, ensuring manufacturers outside the EU can meet their regulatory obligations for these regulated products.
Our comprehensive Importer Services division assists businesses in bringing products into both the UK and EU markets, ensuring full compliance with all relevant regulations including GPSR requirements for economic operators across both jurisdictions.
If you have any questions about our services or need assistance with regulatory compliance, please don't hesitate to contact us.
Best Wishes, Jonathan Phillips
