Case Study 26: Strategic API Supplier Qualification for a Swiss Biotech Firm
Client: A Swiss biotech company sourcing APIs from India, China, and Japan for their oncology portfolio
Challenge:
The client required a strategic qualification plan for six API suppliers in three countries. Ensuring compliance with EU GMP and ICH Q7 guidelines was critical, but engaging separate auditors for each region would have significantly increased costs and complexity.
Solution by Qualifyo:
- Designed a unified supplier qualification program, leveraging Qualifyo’s global network of auditors.
- Conducted pre-audit risk assessments to prioritize critical compliance areas for each supplier.
- Provided a dedicated audit coordinator who managed scheduling, reporting, and follow-ups across all regions.
Outcome:
- All six suppliers were qualified within four months, ensuring uninterrupted API supply for the client’s oncology products.
- The client achieved 35% cost savings by using Qualifyo’s bundled audit services instead of contracting separate providers for each region.
- The streamlined process reduced the administrative burden on the client’s internal team.
