Case Study 17: Compliance Consulting for a Sterile CMO for a Scandinavian Pharma Company
Client: A Nordic pharmaceutical company specializing in biologics
Challenge:
The client needed to qualify a sterile CMO in India for a biologics product under stringent EU and US regulatory requirements. Ensuring sterility and data integrity was critical for approval.
Solution by Qualifyo:
- Conducted a comprehensive pre-audit of the CMO to identify potential regulatory risks.
- Provided consulting services to improve sterility assurance practices, including environmental monitoring and operator training.
- Conducted a follow-up audit to confirm implementation of corrective actions.
Outcome:
- The CMO achieved compliance, and the client secured regulatory approval for their biologics product.
- The client avoided significant delays and saved 30% on compliance-related costs by leveraging Qualifyo’s expertise.
