Case Study 21: Qualification of an OSD CMO for a French Pharma Company
Client: A French pharmaceutical company focused on oncology OSD formulations
Challenge:
The client required a detailed qualification audit of an OSD CMO in India to meet EMA oncology product standards. They also sought to minimize costs due to ongoing budget cuts.
Solution by Qualifyo:
- Conducted a one-day on-site audit, targeting areas critical for oncology drug production: cross-contamination prevention, operator safety, and process validation.
- Streamlined the reporting process with interim updates to the client, reducing back-and-forth communication delays.
- Delivered a final report with actionable insights, helping the CMO address minor deficiencies swiftly.
Outcome:
- The supplier achieved qualification within three weeks, aligning with the client’s production timeline.
- The client saved 35% in audit-related expenses by using Qualifyo’s local auditing team.
- The partnership led to a 20% reduction in CMO production costs, providing long-term savings.
