Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.

We typically encounter three scenarios:

  1. Companies that maintain control of electronic publishing at the corporate and head office level
  2. Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
  3. Companies that have outsourced eCTD entirely

In this article, we will look at the benefits and the limitations presented by the three options presented above.

eCTD Electronic Publishing Acorn RegulatoryThe 3 Options for eCTD Publishing & Submission Services

Companies that maintain control of electronic publishing at the corporate and head office level

For companies that maintain control of eCTD publishing at a corporate level, challenges can be seen with streamlining processes and adjusting procedures for collecting the local national requirements needed for the eCTD submissions.  This is a big adjustment from past processes where core dossier documentation could be filtered out to the local affiliates/partner and they would include the national local requirements to submit to the authorities without a need for further input from the corporate office.  In addition, as final submissions are made at a national level, then gathering/coordinating the registered information of the MAs back to a corporate level to start eCTD lifecycle can be problematic.

Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level

Retaining eCTD maintenance and lifecycle at a local level can be a costly activity.

While the local contact might have all the national documentation requirements and the regulatory history behind the marketing authorisation, the cost involved in training and issuing eCTD software licences to each local affiliate/partner can be costly.  In addition, company-wide eCTD dossier and structure format is hard to maintain when different affiliates/local partners are working in isolation.

Companies that have outsourced eCTD entirely

Others have moved to outsource their eCTD publishing for various reasons.  Many smaller companies do not wish to invest in eCTD software and the intensive and expensive training that staff must undertake to best utilise the eCTD software.  Others simply choose to channel their energies into commercial efforts, and they outsource the eCTD publishing to third party providers.


How We Can Help with Electronic Publishing & eCTD Publishing Services

Support Capabilities

Here at Acorn Regulatory, we offer an array of services covering many challenges faced with global eCTD publishing.  For instance, as we are mainly located in the GMT zone, we can serve as a back-up for submission that needs to be published and submitted urgently.

eCTD Training

Acorn Regulatory also offers various training courses in eCTD that can be catered to individual company needs.

Also, for those companies that make the decision to outsource a portion of full publishing, then don’t worry about training new Acorn Regulatory personnel brought into each project as it grows.  Once Acorn Regulatory is trained at the start of the contract, we will train our internal personnel on your company format and procedures in order to publish effectively as required.  This process allows for any new publishers to be trained accordingly and you will never have to worry about re-training any Acorn Regulatory contract employees.

Re-use Base Dossiers for RoW Markets

We can also provide insight into the best practice to re-use or recycling the base dossier for the rest of world markets. In addition, Acorn Regulatory can assist in outlining a company strategy to implement a standard structure, format, and granularity of eCTD dossier submissions

Conversion Dossiers to eCTD

We can also help if you need assistance with a conversion of NeeS or paper dossiers to eCTD for Baseline submissions.

In-Licensing eCTD Dossiers

Acorn Regulatory can assist in providing valuable insight into what kind of a state the eCTD dossier is in and provide guidance on how to proceed with eCTD structural problems etc.

Full Publishing on a Permanent or Temporary Basis

Others may want to take advantage of our full support packages which can be used for publishing on a permanent basis or a temporary basis to cover the overflow or shortage of publishers available in-house.

If you would like to have a discussion with us about how we might assist you with eCTD, then please complete the form below or contact us on 00353 52 61 76 706.

About the Author:
Eileen Ryan
Regulatory Publishing Manager
Eileen Ryan is the Regulatory Publishing Manager at Acorn Regulatory. In her current role she contributes to the strategic planning/preparation of regulatory submissions in collaboration with other departmental representatives and manages publishing team to ensure the successful publishing of high quality, compliant submissions in the relevant eCTD/NeeS formats to the health authorities. You can read more articles by Eileen Ryan by clicking the link below
Other articles by Eileen Ryan