Consort Medical
Active pharmaceutical ingredient development expert sitting in a lab

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. We also have sites fully equipped and licenced to handle veterinary medicines and controlled drugs.

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 Consort Medical 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 Consort Medical 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. We also have sites fully equipped and licenced to handle veterinary medicines and controlled drugs.

  • EU GMP
  • ISO13485:2016 accreditation
  • MHRA
  • BfArM
  • AIFA
  • US FDA
  • Brazilian ANVISA
  • Japanese PMDA
  • Russian MOH
  • South Korean SFDA
  • Taiwan FDA
  • Turkish MOH
  • Belarus MOH
  • Medical Device inspections by Notified Bodies

 

 

Visit our Location pages to view certificates and licenses

Consort Medical Sites

Our stand-alone quality services

In accordance with our customer requirements, we also offer a range of additional and stand-alone quality services:

  • Registration management (eCTD and EU/US submission support)
  • Filing and maintenance of a portfolio of Drug Master Files
  • EU/EEA importation
  • An appropriate manufacturing infrastructure including Part 11 compliant SAP ERP system, full product and part status/traceability control, cleanrooms and metrology
  • QP certification and release
  • Third-party auditing
  • Method development and transfer
  • Analytical laboratory with broad portfolio of capability (e.g. GC-MS, IR, particle sizing)
  • In vitro diagnostics manufacture and reagent handling

Contact one of our experts for more information about our additional services

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