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Pharmaceutical, biotech, medical device companies

Information or proposal request: eCTD Services

To request more information or a proposal for eCTD services, please complete this form.

Why eCTD?

Who is it for?
Pharmaceutical, biotech, medical device companies and their partners with needs to submit to global regulatory agencies can take advantage of our services today. Use these services instead of or in advance of designing, building, testing and optimizing your own system.

What is provided?
Through our flexible outsourcing / service delivery model, you can take advantage of a full suite of service elements:
  • conversion of source documents to pdf format,
  • organization of content according to eCTD specifications,
  • creation of efficient navigation (structures, bookmarks, hyperlinks),
  • pre-submission quality and compliance assessment, technical and quality reviews

What is eCTD?

The Electronic Common Technical Document (eCTD) is a standard for the electronic submission of regulatory information to regulatory agencies.

Where is the eCTD currently accepted?

Regulatory bodies in the U.S., Canada, European Union and Japan accept eCTD submissions.

Is eCTD mandatory?

In the U.S., electronic submissions are “preferred” or “encouraged”, and for electronic submissions, eCTD is the only acceptable format. In many other countries, electronic submissions and the use of the eCTD format are “encouraged”. Over the long term, the eCTD is expected to become mandatory or near-mandatory.

What are some of the potential benefits – to the applicant - of using the eCTD now?

  • compliance with the agency preference for this format
  • reduced application review and approval time
  • reuse of documents and content for amendments and for global submissions – efficient lifecycle management

What are the potential benefits to the regulatory agencies?

  • increased reviewer efficiency and effectiveness
  • more consistent review
  • electronic workflow