Portfolio and project governance
ePM keeps strategic priorities, project plans, milestones, budgets and risks visible before downstream teams start execution.
The new nData product line supports the full journey from initial idea to market launch with GxP compliant, AI-assisted systems for project management, regulatory affairs, documentation, artworks, clinical trial records and more. It is shaped for pharma teams that need controlled data, accountable workflows and inspection-ready evidence.
Each product addresses a defined operational area, from portfolio and regulatory work to controlled documentation, artworks and clinical trial records. Products can run independently or work together as an integrated ecosystem.
Portfolio and project management layer connecting R&D strategy, execution, resources, budgets, risks and stage-gate decisions.
Regulatory management platform for registrations, submissions, variations, renewals, authority communication and readiness.
Quality control planning platform connecting QC master data, samples, test orders, laboratory resources, scheduling, results and deviations.
Artwork management platform for mockups, versions, approvals, change requests, required documents and lifecycle control.
Controlled document management platform for SOPs, work instructions, policies, forms, records, workflows and audit-ready evidence.
Electronic Trial Master File platform for study documentation, TMF structure, completeness, reconciliation, inspection readiness and audit evidence.
Launch management platform for country readiness, cross-functional activities, milestones, dependencies and market launch evidence.
R&D laboratory platform for experiments, laboratory diaries, samples, structured results and product-to-reference comparison.
Transfer project platform for portfolio care changes such as production site changes, MAH changes, ownership transfers, readiness gates, risks and evidence.
Built from long pharma delivery experience into a connected product ecosystem.
The new product suite builds on two decades of domain experience, implementation work and long-term support for regulated pharmaceutical teams.
Experience from long-running pharmaceutical digitalization projects informs how the new product suite is structured and delivered.
Products follow practical operating models used by regulatory, quality, R&D, clinical and portfolio teams.
Implementation is supported by process analysis, configuration, migration and documentation expected in regulated environments.
Licensing is not tied to the number of users. nData can adapt the commercial model to the product scope, rollout plan and customer environment.
nData products connect the processes, data, workflows and evidence that regulated teams need from early portfolio decisions through market launch and lifecycle maintenance.
ePM keeps strategic priorities, project plans, milestones, budgets and risks visible before downstream teams start execution.
eRA manages registrations and lifecycle activities, while eGO coordinates country launch tasks, dependencies and readiness evidence.
eTRANSFER coordinates lifecycle transfer projects such as production site changes, MAH changes, ownership transfers, readiness gates, risks and evidence.
Pharmaceutical teams often begin with a process challenge: project governance, regulatory visibility, controlled documentation, artwork approvals or clinical trial oversight. nData maps these needs to the right product setup and implementation approach.
Connect the operational need with the right product capabilities, workflow design, data model and validation context.
Connect the operational need with the right product capabilities, workflow design, data model and validation context.
Connect the operational need with the right product capabilities, workflow design, data model and validation context.
Connect the operational need with the right product capabilities, workflow design, data model and validation context.
Connect the operational need with the right product capabilities, workflow design, data model and validation context.
Connect the operational need with the right product capabilities, workflow design, data model and validation context.
Implementation support helps teams translate regulated processes into configured workflows, migrated data, validation evidence and practical user adoption.
Map current workflows, roles, data, documents and approval paths into a product setup that fits regulated pharmaceutical work.
Configure product modules, workflows, permissions, templates and integrations so teams can move from concept to working system.
Prepare master data, legacy records, documents and operating structures for controlled migration into the new product environment.
Support validation planning, configuration records, test evidence and documentation expected in GxP software delivery.
Help business users, administrators and process owners understand the configured workflows and adopt the system in daily work.
Provide ongoing support, change handling and product improvements as processes, regulations and organization needs evolve.
nData is a product company with direct access to senior people who understand pharmaceutical software, implementation and long-term delivery.



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