On-site and remote regulatory operations 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

The scope of work concerned 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.

Project related challenges

  •  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 regulatory operations support 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. Also, documents were to be reused without any rework.

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

Qdossier has it’s in house installations of Lorenz docuBridge and eXtedo eCTDmanager. As a result, updates to introduce the latest country-specific eCTD specifications and subsequent validation can be rapidly performed within Qdossier. This resulted in the company being able to rely on our in house publishing platform to create eCTDs in accordance with the latest country-specific requirements. Subsequently, these eCTDs could be imported in the company’s installation to continue the lifecycle once their system was updated. The company was able to review the eCTDs in Qdossier’s Dossplorer eCTD viewer while using Qdossier’s installation of the eCTD builder.

The benefits of Qdossier's qualified resources and hosted submission management platform for regulatory operations support

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.