Quality and Compliance

The cGMP Compliance Group Quality Team offers consulting services to help clients make informed decisions about the challenges they face on a variety of topics. Our team of experts has completed thousands of projects in almost every facet of pharmaceuticals. biologics, and medical device fields and can provide compliant, effective solutions in an efficient way.

The cGMP Compliance Group specializes in solving challenges. Our experienced compliance consulting professionals will integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and will work side-by-side with you to implement improvement plans and collaborate with your team in addressing those risks.

Any firm that outsources regulated activities such as clinical studies, manufacturing of pharmaceutical products or medical devices, production of raw materials, or laboratory services requires routine qualification audits.

Companies are expected to be compliant and continuously improving. As your partner, we maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product and device lifecycle. Our GxP auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections (PAI).