Our cGMP production facility is regularly audited by our customers and all applicable regulatory bodies including local authorities.
We have consistently passed all such inspections, thanks to our robust quality system. This system relies on:
- Compliance with regulatory and customer requirements;
- Risk management principles;
- Continuous improvement through the monitoring of key performance indicators (KPIs) and their regular review by the management team.
Compliance with regulatory requirements is also assessed during the numerous client and internal audits carried out each year.
Above all, top-level quality arises from the daily commitment of all staff involved in manufacturing activities: We understand that what really matters, beyond regulatory compliance, is the safety of patients.
At Advent, we have helped in preparing regulatory dossiers for about 50 products with different authorities worldwide (the USA, Europe, Canada, etc.). We have interfaced with many governmental entities, and successfully released 100% of our clinical lots, thanks to our strong, experienced Quality Control team.
Our full quality and inspection track record is available upon request, contact us for more details or to assess your regulatory support needs.