Initial authorization applications for new drugs and biologics in the US and Europe are among the most challenging tasks faced by Regulatory Operations. The applications typically include approximately 1,000 documents and hundreds of thousands of pages that need to be authored, reviewed, and published (usually under very tight timelines). While the harmonization brought to us with the eCTD format has certainly increased the efficiency of preparing multiple regional dossiers at once, differences in the required content and format between health authorities persists.

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