A national biotech and medical research agency carried out Phase 1 clinical studies and was looking for assistance in CSR publishing services towards the United States Food and Drug Administration (US FDA). Larger number of documents (5000 pages for each CSR publishing) and improper conversion of data from paper to PDF were the initial challenges Freyr encountered, when reviewing the documents to sort out whether they are as per the US FDA standards.

Read through this document to understand the complete project case on how Freyr performed document level quality check and ensured that the documents were ready for submission to the US FDA.