Regulatory Operations
Our Regulatory Operations (RegOps) team provides submission support in order to proceed with electronic submissions to Health Authorities.
Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).
Our technical editing team offers a unique and specialized skill set that include some of the savviest in the industry.