cGMP Consulting has helped our clients stay compliant with the current Good Manufacturing Processes (cGMP) and implement new technologies since 2001. We are a Chicago based engineering firm providing a range of services to FDA regulated industries.

Engineering Services

Our engineers work with some of the industry leading vendors on numerous projects from developing the User Requirement Specifications (URS) and project management to cost analysis and Functional Design Specifications.

More »

Track and Trace / Serialization System Implementation

cGMP Consulting has experience specifying, commissioning, and qualifying serialization systems. We have validated the serialization process and converted 70 products from non-serialized to serialized versions.

More »

Equipment / Facilities / Utilities Qualification

cGMP Consulting uses a Risk Based Approach (RBA) to Qualification that aligns with the current FDA thinking on qualification.

More »

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.

More »

See how cGMP Consulting can advance your engineering and validation projects.

CONTACT US

Info@cGMPConsulting.com | Give us a call at 312-420-7682