Submissions and Publishing

Dow’s years of experience in writing and publishing regulatory documents for our clients allows us to support your program at all stages of your regulatory publishing needs.

The publishing capabilities at Dow take our clients from start to finish on all regulatory documents, or we can review, prepare and submit any portion of any document as required. We have constant communication with the eSUBS group at the FDA. We can provide you with better lifecycle management for your submission through either electronic or paper templates, structured product labeling, and full publishing capabilities including:

  • Scanning
  • Resizing
  • Deskewing
  • Bookmarking
  • Linking

In addition to traditional paper submissions, Dow is very active with electronic submissions. Through the use of ‘state of the art’ Core Dossier software, Dow has received 2 electronic common technical document (eCTD) approvals in 2005 and 2 eNDA approvals in 2006. In addition to eCTDs and eNDAs, Dow also submits eANDAs and eINDs.

To Learn More

Please contact Karen Hanley, Assistant Director, Business Development & Client Relations, at (x 665), for additional information. Tel: 707.793.2600

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