Regulatory Operations
Source: inSeption Group
Explore how inSeption Group's Regulatory Operations (RegOps) team is able to provide document-level publishing or management of the entire regulatory submission process.
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
inSeption Group
This website uses cookies to ensure you get the best experience on our website. Learn more