Business Imperatives

An Italian multinational pharmaceutical company required expert Regulatory assistance for the preparation and submission of the FDA CARES Act Report 2023 to the USFDA. The scope included compiling the necessary data, ensuring compliance with FDA requirements, and timely submission to meet Regulatory deadlines.

Objectives

The objective was to support the client in accurately preparing, reviewing, and submitting the FDA CARES Act Report 2023 in compliance with USFDA regulations, ensuring seamless and timely regulatory reporting.

Problem Statement

The client faced challenges in understanding the specific requirements of the FDA CARES Act Report, leading to gaps in compliance. Additionally, a lack of familiarity with data validation against the FDA DUNS and NDC databases created potential risks of rejection or delays in submission.

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr prepared a structured report template based on FDA guidelines and shared it with the client for data collection.
  • The data was thoroughly reviewed and verified against the FDA DUNS database and NDC database to ensure accuracy.
  • The validated CSV data was shared with the client for final confirmation, ensuring transparency in the process.
  • Upon client confirmation, the report was successfully submitted to the USFDA via the NextGen portal, meeting all submission requirements.
  • Regulatory Compliance: The client received comprehensive technical support to understand and meet FDA reporting requirements.
  • On-Time Submission: The timely completion and submission of the FDA CARES Act Report 2023 minimized potential delays and compliance risks.
  • Process Optimization: Data verification and validation reduced errors, ensuring an efficient and streamlined submission process.

Freyr’s regulatory expertise ensured the successful preparation and submission of the FDA CARES Act Report 2023, mitigating compliance risks and aligning with FDA expectations.