Regulatory Affairs Submission Process
Challenge
Our client was struggling to handle the ebbs and flows of regulatory submissions with their existing team. They had a core in-house group of publishers who struggled to scale up during increased workload while managing high-priority regulatory submissions. Our client recognized they needed a regulatory publishing team to handle the overflow of electronic common technical document (eCTD) publishing.
Solution
Beacon Hill Life Sciences provided an ad-hoc team of four to six publishers who were available as needed for peak submission periods. The team was fully trained in our client’s standard operating procedures (SOPs) and assisted with converting a backlog of paper submissions to electronic submissions. The teams also filed new submissions over the course of a multi-year assignment.
Achievements
Our client eliminated the backlog of cases and leveraged their internal teams for more pressing regulatory submissions.
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