About

FDAQMS.com is a division of Quality Audit Consulting (QAC). QAC provides Quality Audits to FDA, EU, and MDSAP standards for the Pharmaceutical, Biotech, Cosmetic, and Medical Device Industries.

Located in California between San Francisco and Sacramento, QAC has provided the pharmaceutical and medical device industry with auditing and consulting support since 2018. All consultants have over 20 years Quality Systems, Quality Assurance, Quality Control and Production experience in the pharmaceutical, biotech, and medical device industries.

FDAQMS provides Quality System Consulting and Design Support for small to medium sized Pharmaceutical, Medical Device Companies, as well as for Suppliers, and Vendors to these industries.

Companies we work with include: Over the Counter (OTC) manufacturing companies for production of Hand Sanitizer, Face Mask Manufacturers, Active Pharmaceutical Ingredient Suppliers, Material Suppliers, Chemical Suppliers, GMP Warehouse and Distribution Centers, Drug Product Manufacturers and Contract Manufacturers.

Consultants

All FDA QMS consultants are certified to ISO 9001:2015 and ISO 13485:2016 Guidelines and have over 20 years of industry experience.

Quality Management Systems (QMS)

The Quality Management Systems provided are based upon FDA 21 CFR 210, 211, FDA Guidance Documents, EU Eudralex Vol. 4, ICH Q10, ICH Q7, 21 CFR 820, ISO 9001:2015, ISO 13485:2016, or 21 CFR 820 as appropriate for pharmaceutical or medical device related companies

FDA QMS provides packages for the type of company and size of company. After consultation with your company FDA QMS will provide you with a customized package designed to give you the essential processes and procedures you need to implement your Quality System and to be inspection ready for the FDA or other regulatory agency. Please visit our QMS packages page for further information.