eCTD SERVICES

Microsoft Dynamics ERP For Quality and Compliance

eCTD Services

AXSource offers regulatory submission compilation and filing in the electronic Comment Technical Document (eCTD) format. For more cost-effective filing, let our regulatory experts prepare, validate, publish and review your eCTD submissions. With the added benefit of having an on-site IT division, AXSource is more than ready to support all your eCTD outsourcing needs.

Over the past decade, filling in eCTD has become the mandatory or preferred method for numerous regulatory agencies for various submission types. According to Health Canada for example, as of December 2016, 84% of regulatory activities for drugs were filed in eCTD format.

There are numerous benefits to creating and managing eCTD submissions:

  • Filing eCTD submissions reduces review times, leading to faster approvals
  • Electronic storage/search functions result in faster navigation within and between submissions
  • Going paperless saves on storage space and reduces administrative burden
  • Improved ability to manage product life cycle
  • Cost reductions associated with all of the above

AXSource will assist in:

  1. Supporting you as a small firm with regulatory compliance (mandatory eCTD filing for select regulatory activities as of January 1, 2018, per Health Canada) and infrequent use of the eCTD Service if there are few products;
  2. Transitioning existing regulatory submissions into eCTD format;
  3. Maintaining an expensive IT infrastructure (including hardware/software updates/technical resources) to ensure compliance and reduce costs;
  4. Supporting your Intellectual Property with secure and dependable infrastructure;
  5. Supporting global pharmaceuticals with an influx of new submissions, and finally
  6. Supporting smaller independent consulting companies with largely a separate publishing capability.

eCTD Outsourcing

If you are happy with solely using our well-established infrastructure, AXSource will support smaller companies in ensuring they have access to a compliant capability without the associated high costs. If you are a consulting company, independent consultant or Regulatory Affairs contractor, AXSource will be able to fully support your needs.

Request a meeting with our Business Development Manager today, at info@axsource.ca.

eCTD SUBMISSION REQUIREMENTS: WHAT YOU NEED TO KNOW

To download the FDA document on eCTD submission requirements click here.