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

  • Blood fractionation 

  • Biotech

  • Medical Devices

  • Parenterals

  • Solid Dosage

  • APIs & OCL

Saving Time and Money

Because we're experts in compliance, we know what C&Q documentation needs to stand up to FDA scrutiny. We’re 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.

216 Towne Village Dr, Cary, NC 27513, USA

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