Managing Complex eCTD Publishing for a Large Marketing Authorisation Portfolio

The Challenge

The client had a rapidly expanding portfolio of Marketing Authorisations, exceeding 100 products across multiple regulatory procedures. While some of these dossiers were already maintained in eCTD format, others had not yet been converted, creating a mixed portfolio that required careful management.

The client did not have in-house publishing capability or the specialised software required to prepare and submit eCTD sequences. At the same time, their regulatory teams were responsible for managing a wide range of submission activities across the full product lifecycle, including initial MA applications and ongoing post-authorisation maintenance.

To ensure submissions could be prepared and submitted efficiently while maintaining regulatory compliance, the client required external expertise to manage publishing activities across their diverse portfolio.

Our Comprehensive Approach

Our specialists worked closely with the client’s regulatory teams to manage the preparation, maintenance and submission of their regulatory dossiers in the appropriate electronic format.

Key activities included:

• eCTD Lifecycle Management: We maintained and continued existing eCTD lifecycles for products already established in eCTD format.
• Lifecycle Creation: For new MA applications and products that had not yet been converted to eCTD, we created new eCTD lifecycles to ensure submissions met regulatory requirements.
• Multi-Procedure Support: Submissions were prepared and managed across different regulatory pathways, including purely national procedures, Mutual Recognition and Decentralised Procedures (MRP/DCP), and Centrally Authorised Products.
• Submission Coordination: Our publishing team worked closely with the client’s regional regulatory managers to ensure submission timelines and requirements were met.

Benefits

• The client was able to access experienced publishing support without the need to invest in their own publishing software or build an internal publishing team.
• Our experts were available as required to support submission activities and coordinate closely with the client’s regulatory teams.
• By managing the technical publishing aspects of submissions, we enabled the client’s regulatory managers to focus on documentation collection and preparation of regulatory content within their respective regions.
• Submission timelines were maintained across a large and diverse portfolio of Marketing Authorisations.

Conclusion

This project demonstrates how specialist regulatory publishing support can help companies efficiently manage large and complex MA portfolios. By providing experienced eCTD publishing expertise and coordinating closely with the client’s regulatory teams, we ensured submissions were prepared and delivered in line with regulatory requirements and timelines.

For companies managing multiple Marketing Authorisations or requiring support with eCTD publishing and submission management, our team provides flexible expertise to ensure regulatory dossiers are maintained and submitted efficiently throughout the product lifecycle.