Our Services

Consulting

Commissioning, Verification/Qualification, and Validation

Controls and Automation

Medical Device Design Control

Process and Cleaning Validation

Process Engineering

We have extensive experience in implementing a robust 3 stage Process Validation life cycle based on the 2011 FDA guidance document on Process Validation. This includes development of policies and procedures as well as execution of process design, process qualification and continued process verification programs for various companies. We have several accomplishments in the area of helping companies move through the various phases of commercialization of products.

We also have extensive experience in developing and implementing compliant cleaning validation programs for multi-product equipment, including development of acceptance criteria via MARCO calculations. We also provide laboratory services in the area of cleaning validation, including testing of samples as well as conducting rinse/swab recovery studies, cleanability studies etc.

Another related core competency of ours is implementing and executing risk based strategies for addressing concerns from extractable and leachables from disposable technologies.
Get In Touch

If you are interested in learning more about how our company can help your business, please write to us using this form and we will respond promptly to your inquiry.

 
 
 
 
   
 
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