Quality Assurance
At Apotech, we have worked with a
huge range of clients all around the world.
With consultants and teams present in 30 key life science markets, we have successfully executed projects in over 110 countries and helped a large number of innovative medical devices and products enter the market with complete regulatory compliance.
Keep reading to discover some of our most recent case studies.
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references cGMP ISO 9001 GDPR Trackwise, World Excel, power point Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as…
Navigating the QMSR
What Medical Device Manufacturers Need to Know What is the QMSR? The new QMSR (Quality Management system regulation) is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international consensus standard for medical device quality management systems, ISO 13485:2016, signifying a huge step towards…
Notified Bodies, Approved Bodies & Certification Bodies: What’s the Difference?
Notified Bodies A Notified Body is an organisation designated and authorised by an EU member state to assess and verify the conformity of certain products, (medical devices and IVDs) with applicable EU regulations (EU MDR and IVDR) before they are placed on the market. The conformity assessment usually includes anaudit of the quality management system…