Compliance

Life science companies are being scrutinized by the FDA more than ever. We can help you prepare for an audit, remediate an adverse event or develop a response to an FDA finding.

Remediation:

  • Prepare responses that will be accepted by the agency.
  • Work with you to reduce your risk and use corrective strategies to prevent regulatory actions from arising.
Photo by cacaroot/iStock / Getty Images

Audits:

  • Supplier
  • Contract Manufacture
  • VOE

Assessments:

  • ISO 13485
  • CAPA
  • Validation
  • GMP