Case Study 23: Cost-Efficient Qualification of an OSD CMO for a UK-Based Pharma
Client: A small UK-based pharmaceutical company launching its first OSD product
Challenge:
The client had a limited budget for qualifying an Indian OSD CMO and needed a detailed audit to ensure compliance with MHRA guidelines.
Solution by Qualifyo:
- Conducted a one-day audit with a local expert auditor experienced in MHRA compliance.
- Assessed the CMO’s QMS, granulation processes, and validation master plan.
- Delivered a comprehensive report with a clear risk mitigation plan to address minor non-conformities.
Outcome:
- The supplier was qualified within two weeks, allowing the client to meet their product launch timeline.
- The client saved 45% in costs by avoiding international auditor travel and associated expenses.
- Qualifyo’s cost-effective services allowed the client to allocate more budget toward product marketing.
