Case Study: Regulatory affairs support, Publishing & Submissions and Solutions for a young pharmaceutical company

Project Summary:

Client needed support with the preparation, writing, review, publishing and submission of an IND for a Phase 2 clinical trial in the US.


Performed outsourcing consultancy and services and deliver offered solutions to client. Differentiation between various types of support is provided in the preparation of the IND:

Regulatory operations support related to dossier and document management:

  • Document level publishing (Word and PDF)
  • Compilation of eCTDs
  • Set up and dispatch of eCTD dossier to the FDA via the Electronic Submissions Gateway

  • Setting up and maintaining a file and folder structure for document authoring on Celegence premises for document authoring by client

  • Structuring and organizing the regulatory dossier (e.g., specifying the document granularity)

  • Maintaining an oversight of the dossier status

Regulatory affairs support strategical and procedural

  • Strategic input to document writing
  • Content review of documentation (including consistency and logic checks)
  • Strategic and procedural support (e.g., putting together material for fast-track designation request)
  • Contributing to pre-IND meetings

Technology Solutions:

  • 1
    Dosscriber™: CTD templates for document authoring provided with a Style Guide and MS-Word instructions. Associated with a lean authoring training targeted at anyone involved in (CTD) document writing
  • 2
    Dossplorer™: providing our regulatory dossier viewer available for dossier viewing in a preliminary and final stage of the project. Within this viewing tool, the dossier can be browsed and commented on, without having to exchange the document and dossiers in time consuming manner. Associated with a user training targeted at anyone involved in the project
  • 3
    User access to Celegence’s server to act as eDMS for this project; using a dedicated file and folder structure on a shared drive for the exchange and maintenance of documentation

Project Outcome:

Having all information and documentation on Celegence’s hosted environment, Celegence was able to create a transparent eCTD sequence for the client, fit for submission to the FDA. By using the Dosscriber™ CTD templates, the Dossplorer™ regulatory dossier viewer and eCTD building tool, a time saving and cost-efficient collaboration between Celegence and the client was established. By applying the right-first-time approach, we were able to create standalone eCTD-ready documents, which are future-proof and can be used for multiple purposes (e.g., other regions, products and application types).

Key to the success of the partnership was the commitment of both the Celegence team as the client, combined with a dedicated, concisely monitored planning, proactive work ethics and effective communication by daily or weekly project meetings throughout the project.

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