Inspections from regulatory bodies can be very challenging, especially those made by the FDA.
We can help you with:
- Assessing of your quality management system compliance to QSR (21 C.F.R. 820), identifying vulnerable regulatory areas
- The communication with the FDA, for example replying to Form 483 non-conformances, warning letters, etc.
- FDA inspection preparation, for example mock audits, PMA Preapproval inspections
- Support you during inspections, front office or back office, depending on your needs
Contact me for further information
Office +46 8 621 01 05 or send me an e-mail