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 for one of their Indian API suppliers. They needed an independent audit to identify compliance gaps and avoid potential warning letters.
Solution by Qualifyo:
- Conducted a two-day on-site audit with a focus on FDA 21 CFR compliance, including data integrity and process validation.
- Performed a root cause analysis of past deviations and recommended tailored corrective actions.
- Provided ongoing consultation to the supplier to ensure timely resolution of audit findings.
Outcome:
- The supplier implemented all corrective actions within 30 days, avoiding FDA penalties or import alerts.
- The client saved over $50,000 in potential costs associated with supply disruptions and regulatory fines.
- Qualifyo’s involvement reduced the client’s auditing costs by 40% compared to engaging international audit firms.
