specialing in the preparation and execution of validation IQ/OQ/PQ protocols, compliance documentation for equipment, utilities, processes, laboratory instruments,and computer systems validation, pharmaceutical, manufacturing, GMP training, compliance, protocols, documentation, equipment, utilities, processes, laboratory, instruments, computer systems,quality assurance, project management, 21CFR, PARTS 210,211,2112,213,820 Standards

ABOUT US

Our team is comprised of a group of professionals with considerable experience within the pharmaceutical industry. Educational disciplines consist of chemistry, microbiology, engineering, pharmacy and computer science. Team expertise was not only developed through working with operating companies giving them a unique ability to coordinate with client personnel to assure that all facets of the project start-up and validation are considered. Many of our project leaders have been middle to senior level Quality Assurance Managers, Production Managers or Facility Managers thus having an excellent understanding of industry standards and FDA expectations. Successful projects have been performed throughout North America as well as Internationally. Clients range in size from small to large for pharmaceutical (finished and bulk), biological, medical device and diagnostic manufacturers. cGMP prides itself on all projects regardless of size, being given the same professional attention and management.