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Quality

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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. At Bespak 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 Bespak 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

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