Commissioning & Qualification
We provide commissioning, start-up and qualification services for production facilities, including utilities, process equipment and control systems. Our projects have ranged from single systems to major renovations/expansions to complete biotech and pharmaceutical facilities.
By utilizing the risk based approach outlined in ASTM E 2500, we can successfully leverage vendor documentation for much of the validation.
Do it right the first time
Comprehensive Process Knowledge
Extensive Regulatory Experience
Thorough Process Validation Skills
Exceptional Leadership Ability
APIs & OCL
Saving Time and Money
Because we are experts in compliance, we know what C&Q documentation needs to stand up to FDA scrutiny. We are able to plan and execute C&Q such that the results can be leveraged for use as validation thereby reducing the cost of compliance and shortening the time to market.