A USA-based CRO company was looking for Regulatory support in the filing of initial IND and IND-LCM submissions to the USFDA. Some of the roadblocks presented during the project were as follows:
- Stringent timelines
- High-quality ad-hoc submissions to be filed
- Tracking versions of frequently changed documents and replacing them in eCTD
Freyr team accomplished the tasks within the defined timelines by doing a quick review of all the source documents and validating them using industry-accepted tools.
For a detailed understanding of how Freyr's team extended its support to the client in meeting their expectations and ensured the successful filing of multiple submissions with zero errors, download the proven case.