A Switzerland-based, leading biotechnology company reached out to Freyr to seek Regulatory assistance in LCM submissions for IND applications. The project presented several challenges, such as:
- Stringent timelines
- Working on large volumes of documents, especially modules 4 and 5.
- Tracking versions of frequently changed documents, and
- Replacing them in the eCTD format.
Freyr’s team was able to file the LCM submissions under stringent timelines with zero errors and warnings.
Understand how Freyr addressed multiple challenges and delivered end-to-end Regulatory support to the customer by working on large volumes of documents, especially modules 4 and 5, reviewing frequently changed documents, and tracking all the version changes with a detailed tracker. Download the proven case.