Regulatory Compliance and Quality Systems are all about management – providing the rigour and discipline to ensure the generation of “regulatory -ready” data and take control over product development and implementation
A well executed system drives excellence, bringing your business processes under control and giving you the information you need to drive continuous improvement.We will work with you to implement and develop ownership of a Quality System that is fit for purpose and is compliant to both ISO 13485 and the US FDA 21CFR 820 “Quality System Regulations”. We can also advise on more specialist GxP requirements, including ISO 17025 GLP and specialist quality systems for clinical laboratories and for R&D facilities or design houses.

We can help you with:

Implementation or upgrade of systems for:

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