Our bottom line is ensuring that you have the people, processes, and procedures to meet the standards set forth by leading regulatory bodies.
From installation and start-up commissioning to verification and qualification, our validation SMEs set you up for success so you're able to sustain effectiveness, efficiency, and high quality —no matter where you are in the life science lifecycle.
Our qualified cGMP consultants are immersed in the standards and guidance set forth by the FDA, EMA, and other regulatory bodies including:
21 CFR Parts 11 and 820
FDA 2011 Process Validation Guideline
Eudralex Volume 4 (EU cGMP Guideline)