Regulatory Affairs - Publishing Services

With more than 30 years of Regulatory experience, Dow’s Regulatory Affairs group has successfully delivered for clients by providing a wide range of solutions including: management of submission projects, publishing services, and lifecycle management of Regulatory submissions. Our sound understanding and experience in complying with FDA and ICH guidelines for electronic submissions (as well as CTD paper submissions) make us uniquely qualified to help you be successful.

Outsourcing services include:

  • Submission management
  • Training clients on the eCTD process
  • Document authoring using MS Word templates
  • Document gathering and compilation
  • Pre-processing (bookmarking, hyperlinking, PDF clean-up)
  • Publishing using state-of-the-art software
  • Post-processing (bookmarking, hyperlinking)
  • Quality checks (hyperlinks)
  • Lifecycle management
  • Secure archiving of submissions

Dow offers a combination of Regulatory Affairs and Regulatory Operations to help support clients through the often confusing Regulatory process. Our ongoing relationship with the FDA and Health Canada enhances our ability to obtain agreement on the content and format of submissions. 

Submission types that Dow supports include:

  • Abbreviated New Drug Applications (ANDAs)
  • Investigational New Drug (IND) Applications and IND Amendments
  • Clinical Trial Applications (CTAs)
  • Annual Reports and Amendments
  • Meeting Information Packages
  • New Drug Applications (NDAs), Amendments, and Supplements
  • New Drug Submissions (NDSs)
  • Pre Market Notifications (510k)

To Learn More

Please contact Teresa Johnk, Director of Business Development, Tel 707.285.1508.

<< back to Regulatory & Clinical Affairs