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Commissioning & Qualification

Construction Worker

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

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Comprehensive Process Knowledge
 

Extensive Regulatory Experience
 

Thorough Process Validation Skills
 

Exceptional Leadership Ability

  • Blood fractionation 

  • Biotech

  • Medical Devices

  • Parenterals

  • Solid Dosage

  • APIs & OCL

Factory

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.

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