THinc . . .  a SUBMISSION SERVICES DEPARTMENT

For clients who need electronic or paper regulatory submissions support, we will process, publish, and submit your documents to the health authorities in compliance with regulatory requirements and guidelines. Working with our Regulatory Affairs group, we provide an integrated regulatory and publishing submissions strategy.

Document Preparation

Do you need help in preparing documents for regulatory submission? THinc can

  • Provide document templates (e.g., for clinical study reports, CTD sections)
  • Prepare eCTD-compliant documents for submission (e.g., CTD documents, nonclinical and clinical reports, quality documents) including hyperlinking and bookmarking in PDF format
  • Assemble clinical study reports in accordance with the ICH E3 guidance
  • Verify submission document format and legibility
  • Scan paper/legacy documents and convert to eCTD-compliant format (searchable, hyperlinked, and bookmarked PDF)
THinc