Accelerate Regulatory Data and Operations with AI
Theranext helps pharma teams structure, validate, and operationalize regulatory data across IDMP readiness, migration, transformation, and AI-enabled workflows.
Operational visibility across regulatory data
Theranext gives teams a live, structured view of their regulatory landscape across product records, registrations, variants, and operational datasets.
11,037
RPMP records
3,271
Rgistrations tracked
463
Product variants
IDMP Readiness
Get regulatory data IDMP-ready faster through extraction, structuring, remediation and validation
Data & Doc Migration
Move complex regulatory data and document landscapes into target platforms with control, traceability, and quality
Transformation Delivery
Plan, coordinate, and deliver digital transformation initiatives across systems, data, vendors, and business teams.
AI Enablement
Identify, prioritize, and deliver AI use cases that accelerate data-heavy and high-friction pharma operations.
Build with Theranext
Empower regulatory and data teams to structure, validate, and operationalize critical product information with more control, speed, and traceability.
Structured Data Management
Transform complex regulatory inputs into structured, usable data through guided workflows, business rules, and AI-assisted processing.
Scalable Operations
Support IDMP readiness, migration, and operational deployment across growing product portfolios without multiplying manual effort.
Analytics & Insights
Monitor records, registrations, variants, and processing status through dashboards that improve visibility and decision-making.
Cross-Functional Execution
Bring together business SMEs, data experts, solution architects, and transformation leads to deliver complex regulatory and data programs with confidence.
Platform Capabilities
AI Extraction
Extract high-value regulatory data from SmPCs, RIM records and other complex source documents
IDMP Structuring
Transform extracted regulatory data into structured, IDMP-ready datasets aligned with the right model, fields, and granularity.
System integration
Connect structured data with MDM, RIM, and health authority systems such as Veeva Vault, SPOR, PMS, and FHIR-based interfaces.
Quality & Readiness
Validate completeness, business rules, and cross-system discrepancies to improve regulatory data quality and submission readiness
Move from complexity to execution
Theranext helps pharma teams structure data, deliver transformations, and operationalize AI across R&D processes.
