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Regulatory Compliance and Quality System Management

Quality Management Systems are key to show compliance with the regulations and GxP requirements and show compliance during inspections. QMS is now an integrated part of activities for all Marketing Authorisation Holders and Sponsors and not just limited to manufacturing activities. Real Regulatory has an extensive team of quality experts to support your organisation in setting up a quality management system and providing you with ongoing support as a virtual Quality team. Real Regulatory can help you with different aspects of your quality requirements for pharmaceutical and medical device products:

  • Assisting clients with planning, developing and implementing a quality management system compliant with various applicable European Union (EU) standards (EN ISO 13485, EN ISO 9001), and GxP requirements
  • Gap Analysis reports highlighting gaps/areas of improvement in existing quality systems vs current site activities and regulations
  • Update of an existing quality management system based on gap analysis
  • Providing guidance on all aspects of a quality management system including training, documentation and documentation control, change control, vigilance, GxP, etc.
  • Creation/updating of specific processes (for example risk management as per ISO 14971, recall SOP for MAH, etc…) to meet regulatory and quality system requirements
  • Pre-inspection audits of regulatory and quality management systems to assist in preparation for an inspection and to assess readiness for certification/registration
  • Pre-inspection training (including mock interviews to prepare staff for an audit environment and best conduct for inspections) and how to respond to inspection reports
  • Pre- and post-inspection liaison with Notified Body/regulatory authority inspectors
  • Perform supplier audits on behalf of client companies
  • Conduct due diligence technical reviews and consulting on a product file/dossier
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