A USA-based innovative pharmaceutical company was looking for Regulatory support in filing LCM-grouped submissions to the USFDA. The client’s project presented several challenges, such as:
- End-to-end publishing activities from study documents to the final ESG submission
- Filing of submissions under stringent timelines
Freyr’s team addressed the challenges by working under rigid timelines. The team offered extensive support by conducting a review of all the source documents and tracking each of the version changes made throughout the publishing cycle.
Decode how Freyr worked against time and achieved 100% success in filing the submissions whilst evaluating the time and cost constraints. Download the proven case.