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.

Biotechnology

Pharmaceutical

cGMP Validation LLC

Jesse Gillikin

Laura Gillikin

Todd Buchheit

Ernie Tyler

Dave Whinery

The Validation and Compliance Team at cGMP Validation LLC ensures that clients in the pharmaceutical and medical sectors meet regulatory standards and industry best practices. Comprised of experienced professionals from diverse scientific backgrounds, the team specializes in coordinating validation processes, conducting compliance assessments, and supporting project start-ups to facilitate successful regulatory submissions. Their expertise enables them to manage projects of all sizes with meticulous attention, ultimately helping clients achieve operational excellence and compliance with FDA expectations.

Validation and Compliance Team

About

Team members