About Us

Who We Are

At APEX QMS Consulting, we pride ourselves on providing the highest level of expertise in quality management systems. Our team has first hand experience in manufacturing environments, and specializes in working with companies in the pharmaceutical, medical device, dietary supplement and cosmetic industries to ensure compliance with regulatory standards and improve operational excellence.  We have Certified ISO 13485 Lead Auditors.

Take Your Quality Management to the Next Level

Let us help you navigate the complexities of regulatory compliance and quality systems. Partner with APEX QMS Consulting for expert guidance tailored to your needs.

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Michael Keech, MBA

Global Quality & Drug Safety Compliance Executive | Driving Regulatory Excellence & Operational Impact Across Life Sciences

I worked closely with Nick Gilmour during a complex Life Sciences GMP transformation supporting a global manufacturing network and pre-commercial readiness efforts. Nick brings exceptional judgment and operational depth across quality, regulatory, and compliance, including oversight of batch record review for drug substance and drug product, CMO governance, and global supplier audit programs. He translates evolving GMP requirements into scalable, inspection-ready quality systems that ensure launch preparedness across regions and external partners. Nick consistently bridges strategy and execution, strengthening global oversight models, enhancing risk management, and positioning organizations for successful regulatory inspections and commercial launch. He is a trusted leader known for disciplined delivery, accountability, and driving sustainable impact in highly regulated, multi-site environments.

 

 

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