Case Study 33: Qualification of an OSD CMO in India for a German Generic Drug Company
Client: A German generic pharmaceutical company
Challenge:
The client wanted to onboard an Indian OSD CMO offering competitive pricing but lacked EU GMP compliance. They needed a fast-track qualification process to meet their product launch timeline.
Solution by Qualifyo:
Conducted a detailed on-site audit focusing on critical areas like tablet compression, coating processes, and cross-contamination prevention.
Provided CAPA support to the CMO, including process validation, cleaning validation, and documentation upgrades.
Delivered a comprehensive report for submission to the German regulatory authority.
Outcome:
The client successfully qualified the CMO within four months, avoiding delays in their product launch.
The client is successful in launching their critical product while maintaining compliance with EU GMP standards.
Qualifyo’s streamlined approach saved the client 30% in qualification expenses compared to traditional consulting firms.
