Freyr Solutions and Services
- Conducted a thorough internal review of the documents received from the client
- Identified gaps in the documentation and resolved them within the required timeframe to meet regulatory standards.
- Provided the agency with the most up-to-date documents following the necessary clarifications and updates.
- Compiled, evaluated, and successfully submitted the annual report to the relevant regulatory authority.
- A thorough internal review was conducted of the documents received from the client, the documents were forwarded back to the client for clarification, along with the gaps identified during the review, which was followed by confirmation.
- By ensuring that all stakeholders (Pub team, US local agent, etc.) were actively engaged in the project, the submission was finalized and submitted well in advance to the FDA via the Electronic Submission Gateway after receiving the client’s "go-ahead."
- Optimization of resources and time was achieved throughout the project.
- Product compliance and continuity in the US market were successfully maintained
- The annual report was compiled, evaluated, and submitted to the USFDA in a timely and accurate manner, ensuring full compliance with all regulatory requirements. By adhering to the relevant guidelines, the submission process was completed smoothly, avoiding any delays or non-compliance issues, and maintaining the client's regulatory standing.
