Regulatory operations, done with you
Publishing, Veeva Vault advisory, implementation, consulting and ongoing operations support — delivered by the people who build the DnXT platform and use it on real submissions every day.
Six ways we work with regulatory teams
Publishing Services
eCTD sequences and document publishing run as an outsourced desk, from a plan you review and confirm.
Publishing Services →Veeva Vault Advisory
Vault RIM configuration, labeling, Global Content Plans and Quality–Regulatory connections.
Veeva Vault Advisory →Case Studies
Vault advisory, an on-premise to cloud migration, and an IND assembled from a client-reviewed plan.
Case Studies →Implementation and Migration
Platform set-up and single sign-on, data migration from legacy systems, and role-based training.
Regulatory Consulting
Submission strategy and planning, multi-regional dossier structure, and agency-specific requirements.
Managed Operations
Ongoing publishing, validation and submission support, scaled up or down as you need.
Up and running without an IT project
Platform set-up and SSO
Configuration, single sign-on with your identity provider, roles and access, and connections to the systems you already use, such as Veeva Vault.
Data migration
Bring submission history across from legacy publishing and document systems — such as Documentum, CARA, ISIToolbox or Lorenz docuBridge — or move an on-premise DnXT installation to the cloud with history and integrations intact.
Training and adoption
Role-based training, hands-on workshops and support through the first live submissions.
Expert guidance at every stage
Submission strategy and planning
Strategy, timelines and resourcing for your submissions, with stakeholders aligned before the work starts.
Dossier structure for many regions
Structure Modules 2–5 once and Module 1 per region, across FDA, EMA, Health Canada and the other regions DnXT supports.
Agency-specific requirements
Current specifications and validation criteria applied for each authority you file with.
Extra capacity, or the whole desk
Submission operations support
Experienced regulatory operations people for publishing, validation and submission support, scaled to your workload.
Publishing as a service
For companies without an in-house publishing team: we assemble and publish from a plan you confirm through a secure portal.
Publishing Services →Technology reviews
Regular reviews of your regulatory technology, specification changes and workflows, so you plan ahead rather than react.
Frequently asked
Do we need DnXT software to use your services?
Our publishing and operations services run on the DnXT platform; Veeva Vault advisory and consulting work alongside the systems you already use.
How do engagements start?
With a conversation about your submissions, systems and team. Engagements are scoped to your organisation’s size and needs.
Start with a conversation
Tell us about your submissions, your systems and your team. We will tell you honestly where we can help.
