Case Study: Italian Multinational Pharmaceutical Company achieves successful FDA CARES Act 2023 submission with FREYR

Italian Multinational Pharmaceutical Company submits FDA CARES Act Report 2023 on time with FREYR

An Italian multinational pharmaceutical company required assistance in preparing and submitting its FDA CARES Act Report 2023 to meet USFDA requirements. The client lacked familiarity with the specific reporting mandates and data validation against the FDA DUNS and NDC databases, creating significant risk of rejection or delay. They engaged Freyr for regulatory expertise to ensure compliance and timely submission.

Freyr created a structured report template, collected and verified the client's data against the relevant FDA databases, and shared the validated information for final confirmation. Freyr then successfully submitted the report via the FDA NextGen portal. This process ensured full regulatory compliance and an on-time submission, mitigating risks and streamlining the reporting workflow for the client.