GMP Consulting Services

Compliance Architects^® provides comprehensive, practical cGMP / GMP consulting services to the pharmaceutical, medical device, biopharmaceutical, dietary supplement, and related industries. Our highly experienced FDA GMP consultants learned the ropes of FDA-regulated plant-floor manufacturing in the world’s leading FDA-regulated companies.  Each brings a wealth of experience about the “c” in cGMPs to help you plan, implement, and maintain effective business systems while ensuring your company’s GMP compliance.

What are the cGMPs?

cGMP refers to the Current Good Manufacturing Practice regulations, which are found in 21 CFR 211 (pharmaceuticals), 21 CFR 820 (medical devices), and 21 CFR 111 (dietary supplements) as established by the US Food and Drug Administration (FDA). At their core, the CGMPs outline the requirements for systems that ensure the proper design, monitoring, and control of manufacturing processes and facilities. If properly put into practice, the systems help to prevent poor quality issues such as contamination, failures, and errors.

The Benefits of Hiring a Qualified GMP Consultant

Because the cGMP requirements are designed to be flexible, it is up to each company to decide how best to implement the necessary controls and systems. It’s also important to note that the cGMPs are the minimum requirements and are enhanced through guidance and enforcement practice.

Although the FDA publishes regulations and guidance documents for the industry in the Federal Register, they won’t hold your hand or walk you through the details to ensure you achieve compliance.

Our GMP Consultants bring expertise and experience your business may not have. By using scientifically sound, proven techniques and methods, companies can use modern technologies and innovative approaches to achieve higher quality.

The result of our efforts is production facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable, reproducible, and adequately documented.

Don’t Take Chances with FDA Compliance

Contact us today using the form on the right, and one of our Senior GMP Consultants will contact you.