Quality Management Systems
We have worked with many clients to successfully build or improve Quality Management Systems, including Food, Dietary Supplement, Manufacturing and Life Sciences. The companies are confidential but include Food and Dietary Supplement manufacturers and distributors. • Our business is focused on compliance to either US FDA regulations (e.g. 21CFR Part 111, 21CFR820, 21CFR210/211, 21CFR1271) or ISO Standards (ISO 22000, ISO 9001, ISO 13485, etc.).
We have helped may clients become compliant to the regulations or remediate FDA 483s and Warning Letters, as well as Notified Body Certifications (EU). We also perform on-site Quality Audits and diligence assessments for M&A activities. • We work with many North American and European clients.
Most of our work is performed virtually, and quite a few clients we never meet face-to-face. Our primary goal is to be as flexible as possible and provide our services in an efficient and economical manner; we do not advocate on-site work unless there is no other choice. However, if you prefer for us to be on-site this is not an issue. – With our vast global network, we can offer local in-country support for your regulatory and Certification needs around the world.