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.

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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…

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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. Types of Audits cGMP ISO 9001 GDPR Trackwise, World Excel, power point Scope of work Client quote Apotech’s consultant has been quickly onboarded and managed to get…

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