Case Study

  • March 11, 2025
  • qualifyo

Regulatory Risk Mitigation for a US-Based Pharma Major

Case Study 22: Regulatory Risk Mitigation for a US-Based Pharma Major Client: A top-10 US pharmaceutical company sourcing APIs from India Challenge: The client faced increased regulatory scrutiny from the FDA

  • March 11, 2025
  • qualifyo

Qualification of an OSD CMO for a French Pharma Company

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

  • March 11, 2025
  • qualifyo

Multiple API Audits for a German Pharmaceutical Company

Case Study 20: Multiple API Audits for a German Pharmaceutical Company Client: A large German pharmaceutical company sourcing APIs for its generics portfolio Challenge: The client needed to conduct back-to-back audits