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 Food and Drug Administration (FDA) in compliance with regulatory requirements and guidelines. Working with our Regulatory Affairs group, we provide an integrated regulatory and publishing submissions strategy.

Submission Planning and Management

Do you need help in publishing and submitting your documents to the FDA? THinc can

  • Develop and define paper, electronic, and hybrid submission strategies
  • Create and maintain compliant electronic Common Technical Documents (eCTDs)
  • Develop and define CTD granularity strategy
  • During submission preparation process, coordinate submission components and maintain status log
  • Create and maintain application submission logs
  • Transfer existing eCTD applications
  • Provide paper copies of electronic submissions or reports
  • Convert paper and/or legacy submissions to eCTD format
  • Provide support to internal authors of CTD documents
  • Submit documents via FDA Electronic Submissions Gateway
THinc