Are your facilities ready for an FDA inspection or inspection by another global regulatory agency? Do your contracted facilities meet GXP compliance and quality standards?
Cardinal Health Specialty Solutions provides the pharmaceutical compliance and GXP auditing services necessary to help you ensure that the answers to these questions are “yes”.
Four decades of global auditing experience
Cardinal Health successfully prepares global companies for regulatory agency audits through the execution of regulatory compliance and GXP auditing services. Each of our industry-trained experts has more than 15 years of experience and provides pharmaceutical compliance services at all phases of the product lifecycle.
Pharmaceutical auditing expertise
Our core capabilities include conduct of the following compliance services:
- Pre-approval Inspection (PAI) readiness
- Good Manufacturing Practices (GMP) audits
- Good Laboratory Practices (GLP) audits
- Good Clinical Practices (GCP) audits
- Quality System Regulations (QSR)
- Supplier Qualification audits
For a complete listing of our pharmaceutical auditing capabilities, including GMP audits and FDA inspection preparation services, please download our brochure
Saving you money and time
Our regulatory compliance experts ensure that your quality systems, process validation and all other aspects of your in-house and contracted facilities are in compliance with global regulatory agency requirements and quality standards.