Independent Consultants
Good Pharma Quality Consultants is a group of independent consultants in the areas of GLP, GCP, and GCLP compliance. We work independently and collaborate with your teams as needed to tailor our support to your organization's needs and provide informed and well-rounded support.
Our experience in various FDA regulatory settings allows us to provide the support you need, whether it's filling a temporary vacancy, helping you adjust to a fluctuating workload, reviewing raw data, providing equipment and computer system validation, writing SOPs, or identifying gaps in compliance, we have the expertise to bring your organization forward and reduce compliance risks.
“Good Pharma Quality Consultants have years of hands-on experience building, shaping and improving quality programs at any stage of development. The team is also experienced in implementing and training Research organizations that are transitioning from strictly research to performing regulated studies. They are efficient, professional and focused and I’ve turned to them for their expertise for the last decade.”
What We've Achieved
Developed quality systems for a large pharmaceutical company to improve inspection readiness processes across multiple sites.
Transitioned a research histology laboratory to a GLP histology laboratory, helping the organization achieve faster timelines and reduced costs.
Developed training program for researchers on protecting patient privacy and the ethical use of human biospecimens in research.
Advised teams on decommissioning or relocating GLP biopharmaceutical research sites.
Standardized qualification and change management procedures for a multisite organization.
Designed and established an equipment validation department from the ground up, including the development of new processes, standard operating procedures, and an electronic project management and reporting system.