Case Study

Securing EU Approval for a First-Time Marketed Product

Project Summary

Assisted a young, research-oriented pharmaceutical company in registering its first Marketing Authorization Application in the EU. The client had limited experience with regulatory authoring, as their expertise was primarily in scientific journal publications. They also lacked critical regulatory infrastructure, including an electronic Document Management System (beyond basic tools like SharePoint and file shares) and an eCTD builder.

Highlights:

Provided a comprehensive overview of pharmaceutical development, regulatory affairs, and ICH CTD requirements, referencing relevant guidelines and regional directives.

The team advised the client on regulatory authoring styles, document structuring, and organization, while managing eCTD publishing and submissions for the initial MAA and follow-up sequences. We also supported Scientific Advice and pre-submission meetings.

Delivered a workshop to train authors, reviewers, and approvers on marketing authorization requirements and eCTD specifics for biosimilars

Supplied future-proof submission templates with prepopulated content and integrated regulatory guidance. Using a hosted eCTD tool, the eCTDs were built with proper granularity, naming conventions, and eCTD-readiness

Source documents were exchanged via SharePoint, SFTP, or email, and Dossplorer™ facilitated review and approval before submission to health authorities through gateways like Eudralink

Project Achievements

The client gained a better understanding of the importance of a stable production process and how to address changes effectively

They successfully created standalone, eCTD-ready documents with minimal post-finalization publishing, enabling reuse across regions, products, and application types

Using our hosted environment and Dossplorer™, transparent eCTD sequences were shared with the customer and third-party contributors without the need for multiple exchanges or version discrepancies. Draft sequences could be reviewed, commented on, and viewed in the context of the full lifecycle, ensuring a clear and up-to-date status without obsolete documents

The customer met all project timelines

Project Success

The client achieved timely EU approval by creating reusable eCTD-ready documents, streamlining reviews via Dossplorer™, meeting all project deadlines, and improving change management for long-term submission efficiency across multiple regions and products..

Bringing Your First Product to the EU Market?

From regulatory training and submission templates to eCTD publishing and MAA submissions, Celegence supports first-time and experienced pharma applicants in achieving timely approvals. Email us at info@celegence.com

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From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.

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