On-site and remote support

A Tier 1 pharmaceutical company wanted to hire additional support for their Regulatory Operations Department. Initially these services were to be provided on site. Quickly the services could be provided remotely using the company’s laptops and accounts, saving on costs for traveling and accommodation. Over time, the company handed over all eCTD/NEES support for their registered products and an initial MAA for an innovative product.

Submission management for Europe, Gulf region and South Africa

Managing eCTDs and NEESs for registered product within Europe (EU and beyond), GCC and South Africa, and an initial MAA for an innovative product in the EU.

Navigating peaks and troughs in workload

Managing eCTDs and NEESs for registered products always concerns peaks and troughs in workload. This was one of the reasons for the company to outsource these activities.

Planning is as good as it gets; there are always delays in delivery dates of documents, whereas the planned submission dates hardly slip.

Lack of consistency in data and document naming, locations of documents and eCTD-readiness of documents within and across countries.

Management in a large company of a validated eSubmission tool that requires many country-specific updates over a year.

Description of the project

Based on our experience, Qdossier team members were proactive in advising for areas for improvement to align dossiers across products, countries and regulatory affairs individuals. This included advice on document granularity, document naming, document locations in the eCTD/NEES and data consistency across the cover letter, application form, eCTD metadata and delivery files.

As part of the planning, as much as possible was to be done off the critical path and documents were to be reused without any rework.

Having a pool of people that is 2 to 3 times as big as needed for the regular workload for this client, Qdossier was able to easily scale up and -down to support the client.

Qdossier has it’s in house installations of Lorenz docuBridge and eXtedo eCTDmanager. Updates to introduce the latest country-specific eCTD specifications and subsequent validation is rapidly performed within Qdossier. In some cases the company was able to rely on our in house publishing platform to create eCTDs in accordance with the latest country-specific requirements. These eCTDs could subsequently be imported in the company’s installation to continue the lifecycle once their system was updated. While using Qdossier’s installation of the eCTD builder, the company was able to review the eCTDs in Qdossier’s Dossplorer.

The benefits of Qdossier's qualified resources and hosted submission management platform

The customer did not have to worry about (the number of) qualified resources and actual preparation of the dossiers on the Qdossier hosted submission management platform. In addition, they learned how to make dossiers more transparent and benefitted from this transparency with better understanding of the regulatory status of dossiers. The efficiency gain by the usage of Dossplorer for internal review purposes, without having the need to exchange and unpack zip-files, was very much appreciated by the users at both Qdossier and the company.