Do you want Pre-Approval Inspections (PAIs) done right the first time?

PAI's are a significant milestones for market entrance in FDA-regulated industries. If your team requires assistance with the diligent preparation then our experienced consultants can assist your team prior to the PAI with the following:

• • external compliance reviewers

  • auditors to conduct mock audits

  • remediation activities

  • training for what to expect and how to be prepared

  • validation

Contact us now to discuss your PAI requirements. Our consultants have decades of experience with the FDA, pharmaceutical, device, biotech and contract research organizations.