Now live · Freyr Agentic Fleet
Meet Via: Variation
Identification Agent
The agentic intelligence layer for post-approval change management.
Turn complex regulatory changes into clear, submission-ready decisions in minutes, simplifying post-approval variation assessment with speed, confidence, and full traceability.
Up to 80%
faster assessments
Expert-level
guidance-driven reasoning
Explainable
outputs with traceable rationale
Variation Type
CMC Change
Filing Pathway
Impact Assessment
Transforming Post-Approval Variation Assessment
Via is a Variation Identification Agent designed to simplify post-approval change management for regulatory teams. It analyzes a change, reasons across global regulatory guidance, and identifies the correct variation type and submission requirements. The result is faster, consistent, and fully traceable decisions across markets.
Unlike generic AI tools, Via is grounded in Freyr's regulatory knowledge graph curated by domain experts. It reasons through regulatory logic, asks clarifying questions when needed, flags ambiguity, and produces a rationale that experts can review, refine, and approve.
Every post-approval change assessment begins with three critical questions: Which products are affected? Which markets are impacted? What regulatory action is required?
Answering them often means navigating disconnected product records, registration data, and regulatory guidance across multiple systems.
Meet the Team Behind Every Assessment
Powered by the Freyr Agentic Fleet
Product Identification Agent
Understands product-specific context including product type, dosage form, manufacturing details, and product hierarchy.
Answers
Which products are affected?
➡
Market Identification Agent
Understands registration and market-specific context including approvals, authorization status, marketed registrations, and country applicability.
Answers
Which markets are impacted?
➡
Variation Identification Agent
Applies regulatory intelligence to determine variation classifications, filing requirements, documentation expectations, and regulatory rationale.
Answers
What regulatory action is required?
Pia, Mia, and Via bring product, market, and regulatory intelligence together in one connected assessment workflow.
See it live
Watch Via in Action
See a post-approval change go from ambiguous input to market-ready clarity.
The Challenge: Post-Approval Complexity
Post-Approval Isn't the End. It's the Beginning.
Post-approval change management is unavoidable, yet organizations still struggle with slow, expert-dependent, and inconsistent decision-making across global markets.
High Volume
Thousands of change assessments across products, sites and markets
Fragmented Guidance
Different regional rules, documentation expectations, and filing pathways
Manual Classification
Time-consuming guidance navigation and conditional logic
Complex Cross-Functional Coordination
Global, regional, QA, CMC, and local teams may interpret the same change differently
The bottleneck is not the change. It is figuring out what the change means everywhere.
Core Capabilities
Not Just Automation. Agentic Regulatory Intelligence.
Instant Variation Identification
Interprets variation type and submission requirements instantly.
Global Regulatory Intelligence
Navigate country-specific regulations across markets with precision.
Advanced Regulatory Reasoning
Navigates complex conditional logic and provides multiple valid pathways.
Explainable, Traceable Outputs
Trustworthy & transparent outputs with clear rationale.
Agentic Intelligence at Scale
Handle high-volume change assessments across portfolios.
Trustworthy AI Decisions
Surfaces ambiguity instead of making assumptions.
Measurable Impact
What Changes with Via.
01
Reduce variation assessment time by up to 80%
02
Reclaim 100s of FTE hours annually across global portfolios
03
Reduce Timelines for Adhering to Regulatory Commitments
04
Strengthen Internal Capability and Operational Capacity
05
Shift from operational classification to strategic regulatory work
06
Build a More Compliant, Regulatory-Ready Organization
Transform the way you manage post-approval changes.
FAQs
Questions Regulatory Teams Usually Ask
01
Does Via replace regulatory experts?
No. Via supports and enhances regulatory decision-making. Final regulatory determinations remain with qualified professionals.
02
What happens when information is incomplete?
Via asks clarifying questions or flags limitations instead of making assumptions.
03
Is customer data used to train the AI?
No. Customer data is not used for model training.
04
Can assessments be shared?
Yes. Assessments can be shared as static, read-only views for team or stakeholder review.
05
How quickly can teams access Via?
Sandbox or production access in 1-3 business days - no data migration or integration required.
06
What is the role of the knowledge graph in Via?
Via’s knowledge graph serves as the foundation for its regulatory reasoning. It structures and connects curated regulatory intelligence, enabling Via to deliver accurate, traceable, and guidance-driven assessments while reducing the risk of hallucinations or unsupported conclusions.
Fast to access. Easy to test. Built for serious regulatory work.
