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.

Overview of expertise:

  • Document-level publishing services
  • Submission-level publishing services
  • Redaction and anonymizing services for public disclosure
  • Quality control of dossier
  • Electronic submission strategy
  • Strategic consulting
  • Expert knowledge of 21 CFR Part 11, eCTD, ICH, and other applicable regulatory requirements
  • Advanced use of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, and document publishing systems