Case Study 8: Onboarding a High-Risk Supplier for a Scandinavian Pharmaceutical Company
Client: A pharmaceutical company based in Sweden specializing in niche APIs
Challenge:
The client was hesitant to onboard an Indian API supplier flagged as high-risk due to past compliance issues. They needed a detailed assessment to evaluate the supplier’s current capabilities and risks.
Solution by Qualifyo:
- Conducted a detailed risk-based audit focusing on process controls, CAPA effectiveness, and regulatory history.
- Performed a comprehensive review of data integrity systems to identify hidden gaps.
- Provided ongoing consulting support to the supplier to rectify major deficiencies and improve compliance practices.
Outcome:
- The supplier successfully addressed 95% of compliance gaps within 30 days.
- The client onboarded the supplier, reducing API procurement costs by 25% without compromising quality.
- Qualifyo’s involvement minimized the client’s audit costs by 30% while mitigating onboarding risks.
