Case Study 6: Rapid Supplier Qualification for a French Pharmaceutical Company
Client: A mid-sized pharmaceutical company in France
Challenge:
The client needed to qualify a new API supplier in India for a critical drug product under a strict regulatory timeline. Their internal audit team lacked bandwidth, and delays risked missing their EMA submission deadline
Solution by Qualifyo:
- Deployed a local, highly experienced auditor from Qualifyo’s network, reducing travel time and expenses.
- Conducted an on-site audit focusing on API manufacturing, cleaning validation, and adherence to EU GMP guidelines.
- Used streamlined communication tools to provide interim updates, reducing approval cycles for audit findings.
- Delivered the audit report within 5 business days, detailing a roadmap for corrective actions.
Outcome:
- The supplier resolved all critical findings within 4 weeks, achieving full qualification.
- The client met their EMA submission deadline, avoiding potential delays.
- The project cost was reduced by 40% compared to engaging an EU-based audit team, thanks to Qualifyo’s local expertise.
