Regulatory & Quality

Manufacturing, packing and supplying products that will be used on vulnerable patients means that everything we do must have the Rocialle stamp of approval in order to help people live Healthier & Happier Lives.

We must adhere to various Regulations and have an exemplary QMS (Quality Management System) to ensure we’re meeting the required standards.

We are experts in our field.

We hold ISO 13485 certification as well as Manufacturer’s and Wholesale Dealers Licences for medicinal products, working to cGMP & cGDP standards. We adhere to both UK and EU regulatory requirements and are currently working through all the recent & upcoming regulatory changes following the UK’s exit from the EU and the changes brought about by MDR. With our high standards & strict governance, we are proud to provide the highest quality products and services.

We are also proud to be ISO 14001 certified, demonstrating our commitment to environmental responsibility. This internationally recognised standard reflects our dedication to managing and reducing our environmental impact through effective environmental and quality management systems. Sustainability isn’t just a goal — it’s part of how we operate every day.

Annette Callaghan, Head of Regulatory and Sterilisation

“The Regulatory and Sterility Assurance Team at Rocialle has many years experience in medical device and pharmaceutical compliance and we put patient safety at the forefront of everything we do.”

Annette Callaghan, Head of Regulatory and Sterilisation