Case Study 3: Audit Support for a Virtual Pharma Company in the UK
Client: A virtual pharma company specializing in niche generics
Challenge:
The client lacked internal resources for supplier qualification audits and needed to evaluate multiple CMOs (Contract Manufacturing Organizations) in Eastern Europe for a new product launch.
Solution by Qualifyo:
- Deployed a team of expert freelance auditors familiar with Eastern European regulatory landscapes.
- Conducted on-site audits of three CMOs within a tight six-week timeline.
- Evaluated adherence to EU GMP standards and assessed production capabilities for niche generic drugs.
- Delivered comparative audit reports to assist the client in decision-making.
Outcome:
- The client shortlisted a reliable CMO with demonstrated compliance and production capabilities.
- The project was delivered within the stipulated timeline, meeting market launch targets.
- The client saved 30% in costs compared to hiring a full-time audit team
