cGMP Validation LLC

cGMP Validation was established in 1997 as a full service validation/compliance firm offering services for the pharmaceutical, bulk pharmaceutical, animal health, biotechnology, biologics, medical device and medical diagnostic industries. 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.

Website

http://www.cgmpvalidation.com

External link for cGMP Validation LLC

Industry

Pharmaceutical Manufacturing

Company size

51-200 employees

Headquarters

Shawnee, Kansas

Type

Privately Held

Founded

1997

Specialties

Facility Commissioning/ Validation, Equipment/ Instrument Qualification, Medical Device V&V, Cleaning Validation, Computer Validation, GMP/ 21CFR Part 11 Auditing, GMP Training, SOP/ Policy Authoring, IT Risk Assessment, and Periodic Evaluation/ Revalidation