THinc . . .  a SUBMISSIONS 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.

Submission Planning and Management

As part of the submission planning and management, THinc can

  • Develop and define paper, electronic, and hybrid submission strategies
  • Create and maintain compliant electronic Common Technical Document (eCTD) submission structure and documents
  • Transfer existing eCTD applications
  • Provide paper copies of electronic submissions or reports
  • Convert paper and/or legacy submissions to eCTD format
  • Provide support to authors of CTD documents
  • Submit documents via FDA Electronic Submissions Gateway
THinc