→ Regulatory Affairs
Variation triggers and submission packages
A safety-driven label change carries with it the regulatory consequence: the affected territories, the variation work, the deadlines: without that work having to be re-discovered.
One safety event.
Ten regulatory realities.
One source of truth
Krevyos manages the full post-commercialization safety lifecycle from a single adverse event reaching your inbox to a validated E2B(R3) submission landing in FAERS, EudraVigilance, VigiMed, PMDA, or any of ten-plus regulated gateways: without you maintaining a separate safety database per region.
- Domain owner
- QPPV (EU) · PV Officer (national) · Head of Drug Safety · Drug Safety Scientist
- Regulated gateways covered
- FAERS · EudraVigilance · VigiMed · VigiFlow · PMDA · MFDS · NMPA · ANVISA · Health Canada MHPD · plus more
- Reporting standards
- ICH E2A · E2B(R3) · E2C(R2) · E2D · E2E · ICSR · PSUR / PBRER · DSUR · RMP · REMS · PSMF
A note on automation
The algorithm recommends. A qualified human decides.
Krevyos Pharmacovigilance is a Non-Device Clinical Decision Support platform by design. Algorithmic outputs across the system are advisory: a qualified human professional reviews and confirms every determination before it becomes a regulatory action.
This is a deliberate architectural choice, not a limitation. It keeps Krevyos firmly outside Software-as-a-Medical-Device classification while doing the heavy analytical lifting a PV team would otherwise carry by hand.
The result is a platform with a 21 CFR Part 11 audit trail, full transparency on how each recommendation was reached, and a regulatory posture that is BIMO, GVP, and WHO Prequalification inspection-ready by default.
Capabilities
ICSR intake, triage, and processing
Individual case safety reports captured from spontaneous, solicited, and literature-sourced channels, with the coding, causality, follow-up, and duplicate-handling work that ICH E2B(R3) compliance requires.
- ICH E2B(R3)
- MedDRA coding
- WHO-UMC causality
- Duplicate resolution
15-day expedited reporting
Serious, unexpected adverse reactions routed to the right authority within the deadlines that each regime requires: FDA, EMA, PMDA, MFDS, Health Canada, and Latin American authorities across the major markets. The reporting clock is tracked from detection to acknowledgment as part of the operation rather than as a manual count.
- 21 CFR 314.80
- EU Reg. 726/2004
- ICH E2D
- Regional regs covered
Periodic safety reporting
PSUR and PBRER preparation per ICH E2C(R2), with EU EURD-list cadence and US PBRER commitments handled in parallel. The platform distinguishes between ANDA-generic and EU MAA holders, applying the relevant exemptions and requirements automatically.
- ICH E2C(R2)
- PSUR / PBRER
- DSUR
- EU EURD cadence
- 21 CFR 314.98
Signal detection and risk management
Established statistical signal-mining methods, applied continuously against the safety dataset and surfaced for qualified review per ICH E2E. EU Risk Management Plans and US REMS handled as versioned, approval-gated records across the product lifecycle.
- ICH E2E
- Disproportionality methods
- EU RMP
- US REMS
Multi-region reporting from one record
A single canonical case record is reported into the formats and regional extensions each authority requires: including the major regional profiles in force across the EU, North America, Asia, and Latin America. What is one event in the operation appears as the right submission in each regulated market.
- Regional E2B(R3) profiles
- Authority-specific extensions
Transmission, acknowledgment, and validation
Submissions transmitted into the regulated gateways operated by FDA, EMA, PMDA, MFDS, Health Canada, and the LATAM authorities. Acknowledgment status is tracked end-to-end. Pre-submission validation against schema and business rules catches issues before transmission rather than after a deficiency.
- FDA ESG
- EudraVigilance
- VigiMed / VigiFlow
- Acknowledgment tracking
Audit-grade trail and inspection readiness
A 21 CFR Part 11 audit trail across every action, with GDPR- and HIPAA-aware handling of patient data, and full transparency on how each algorithmic recommendation was reached. The system is inspection-ready as a steady state: BIMO, GVP, and WHO Prequalification not as a sprint.
- 21 CFR Part 11
- GDPR / HIPAA
- BIMO / GVP / WHO PQ
- PSMF
Touchpoints
→ Labeling
CCDS as the live anchor
Safety updates and labelling stay aligned across markets, so the SmPC, PIL, and patient-facing labels in each territory reflect the same underlying safety position.
↔ Quality Management
Deviations, complaints, and quality defects
Product quality complaints and safety reports often describe the same underlying event. Krevyos handles them together so neither investigation loses the other's context.
← Organizations & Resources
SDEAs and partner data exchange
Safety Data Exchange Agreements with partners are held alongside the cases they govern, so reconciliation periods and obligations are part of the operation rather than buried in contract appendices.
← Clinical Bioequivalence
Pre-marketing safety from BE studies
Adverse events from bioequivalence studies feed the same safety picture as post-marketing data, so a product's safety profile is continuous rather than reconstructed at each phase.
→ Market Access
Real-world evidence and benefit-risk
Benefit-risk assessments and post-marketing safety information feed the commercial and HTA work without being rebuilt for it from scratch.
Outcomes
- 10+
Regulated gateways from a single case record
One canonical record reported into the regulated gateways operated by the major authorities, instead of ten parallel safety databases maintained in step.
- −70%(indicative)
Time spent on PSUR/PBRER authoring
Periodic reports built from the live safety picture, rather than reconstructed each cycle.
- 15-day
Clock tracked from event to acknowledgment
Expedited reporting deadlines met against a clock that runs from detection to acknowledgment as part of the operation, rather than being maintained by hand.
Schema and validation errors reaching the agency
Pre-submission validation against schema and business rules catches issues before transmission, and acknowledgment status is tracked end-to-end so failures are handled internally rather than as a deficiency.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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