RecipharmNewsEventsCareersInsights Home > About > Quality Quality All of our sites meet international and local regulatory requirements All of our sites have a strong track record of successful global regulatory inspections. Medical device quality management systems drive our high product standards Adherence to quality and regulatory requirements is key to the successful supply of products to the pharmaceutical, medical and diagnostics industries. We understand the interface between drug and device. We have a wealth of experience in working with customers to navigate the regulatory and quality pathway; from early stage through to full commercialisation. Our quality assurance driven culture is based on continuous monitoring and improvement, where meeting the expectations of the customer is our highest priority. By complying with current regulations, we maintain the highest standards for our products over millions of devices every year. The Operating Board has established the Quality Management System, conforming to ISO 13485, to ensure that everyone works to the same, consistent standards and intent. Our systems can be tailored to our customers’ specific needs to facilitate rapid transfer and commercialisation of high-quality product to market. All of our sites meet international and local regulatory requirements All of our sites have a strong track record of successful global regulatory inspections. EU GMP ISO 13485:2016 certification MHRA US FDA Medical Device inspections by Notified Bodies Visit our Location pages to view certificates and licenses Bespak Locations Our stand-alone quality services In accordance with our customer requirements, we also offer a range of additional and stand-alone quality services: Filing and maintenance of a portfolio of Drug Master Files An appropriate manufacturing infrastructure including Part 11 compliant SAP ERP system, full product and part status/traceability control, cleanrooms and metrology Method development and transfer In vitro diagnostics manufacture and reagent handling Contact one of our experts for more information Contact an Expert Find out more Page Company Read More Page Locations Read More Page Sustainability Read More Bespak Europe Ltd Registered office: Bergen Way North Lynn Industrial Estate, King’s Lynn Norfolk PE30 2JJ. United Kingdom Quick Links Products Services Insights About us About Recipharm Contact Us Email Linkedin Privacy NoticeLegal StatementCookie PolicyTerms & ConditionsModern Slavery Act StatementStatement of Investment PrinciplesSitemap Website by Farrows By continuing to browse the site you are agreeing to our use of cookies I Understand