We aim to serve our clients by providing outstanding customer service and effective cGMP support.
Track and Trace Serialization
We have worked on developing serialization systems for clients in the pharmaceutical industry since 2011.
Quality System Development and Support
Our major clients are large pharmaceutical companies with well-defined quality systems.
Equipment / Facilities / Utilities Qualification
cGMP Consulting uses a Risk Based Approach (RBA) to Qualification that aligns with the current FDA thinking on qualification.
Process and Cleaning Validation
Our engineers have the ability to generate cleaning matrixes, assess clean-ability, recommend cleaning agents, and develop the associated documentation to confirm that your process is in compliance.
A major category of our work has been in implementing new technologies to manufacturing processes.
New initiatives often require additional support. We have senior level staff with an excellent track record of working with many functional areas to make significant changes in plant operations.
Computer System Validation
We have validated many types of computerized systems from stand-alone instruments with associated controls to enterprise level enablement.
We have American Society for Quality (ASQ) Certified Quality Auditors (CQA) on staff with many years of experience in auditing facilities in the US and abroad.