Case Study 31: Unified Supplier Qualification for a Scandinavian Pharma Company
Client: A Scandinavian pharmaceutical company with a focus on specialty APIs
Challenge:
The client needed to audit multiple API manufacturers in India, China, Japan, and Europe to ensure compliance with EU and US FDA regulations. They wanted to avoid the complexity of hiring multiple audit service providers.
Solution by Qualifyo:
- Developed a unified qualification framework for the client’s global suppliers.
- Conducted on-site audits in all regions using local auditors with expertise in GMP compliance.
- Provided centralized project management and a single point of contact for the entire qualification process.
Outcome:
- The client qualified eight suppliers within four months, meeting regulatory requirements without delays.
- Audit costs were reduced by 35% due to Qualifyo’s bundled service model.
- The client avoided the administrative burden of coordinating with multiple auditing firms.
