MEET drugcard`s
AI AGENT
FOR AUTOMATED LITERATURE SCREENING
Configurable AI for literature monitoring, keeping experts in control with full traceability.
BENEFITING
FROM OUR TECHNOLOGY
DRUGCARD IN NUMBERS
Continuously expanding our reach, coverage and impact
Audits & Inspections
successfully passed by DrugCard
Countries
medical journals coverage
Local journals
continuously monitored
Customers
all over the world
Pharmacovigilance automation built for PV reality
DrugCard provides pharmacovigilance automation software designed around the operational challenges modern PV teams face every day.
LESS ROUTINE. MORE FOCUS.
1
AI-powered automation reduces repetitive work, so PV experts can focus on analysis and critical decisions.
TAILORED TO YOUR SCOPE.
2
Local journals and sources added quickly on request, so coverage expands with your regulatory footprint.
TRACEABLE. EXPERT-LED.
3
Every workflow stays documented and audit-ready, shaped by PV experts around real client feedback and needs.
Configurable AI
for LITERATURE MONITORING
DrugCard’s AI Agent works directly inside your literature monitoring workflow.
- Automates screening, categorization and repetitive review while your team stays in control of every decision.
Three Levels of Autonomy
Level 1
AI agent
Screening
Identifies pharmacovigilance-relevant literature and automatically filters out non-PV publications.
Level 2
AI-assisted
Triage
Keeps only product-relevant publications and suggests Safety Case or Safety Information categories for expert review.
INCLUDING LEVEL 1
Level 3
Autonomous
Categorization
Automatically assigns Safety Case and Safety Information categories while preserving complete audit traceability.
including LEVEL 1,2
Level 1
AI agent
Screening
Identifies pharmacovigilance-relevant literature and automatically filters out non-PV publications.
Level 2
AI-assisted
Triage
Keeps only product-relevant publications and suggests Safety Case or Safety Information categories for expert review.
INCLUDING LEVEL 1
Level 3
Autonomous
Categorization
Automatically assigns Safety Case and Safety Information categories while preserving complete audit traceability.
including LEVEL 1,2
FULL TRACEABILITY
Every action, decision and categorization is logged, reviewable and audit-ready.
CONTINUOUS MONITORING
Schedule automated runs and monitor every execution with live statistics and measurable time savings.
EXPERTS STAY IN CONTROL
AI automates repetitive work while PV specialists keep full control over every critical decision.
Continue the workflow with connected regulatory intelligence and adverse event management.
Connected pharmacovigilance platform
The DrugCard pharmacovigilance platform connects literature monitoring, regulatory intelligence and safety database within a unified safety workflow.
REGULATORY INTELLIGENCE
Track regulatory updates from global and local authorities in one connected workspace.
TARGETED MONITORING
Track only the authorities and countries relevant to you — nothing else.
AI pre-categorization
Every regulatory update is automatically classified into the right category the moment it’s collected — no manual sorting required.
SECURE & TRACEABLE
FDA 21 CFR Part 11–compliant, with ISO 27001 and SOC 2 Type II–secured infrastructure.
Safety Database
Manage adverse events from intake to regulatory exchange in one compliant workflow.
AI-POWERED SIGNAL DETECTION
Identify potential safety signals and prioritize risk assessment.
ADVANCED REPORTING
Generate compliant reports and support deeper safety analysis.
E2B(R2/R3) SUPPORT
Exchange standardized safety data across regulatory systems.
REGULATORY INTELLIGENCE
Track regulatory updates from global and local authorities in one connected workspace.
TARGETED MONITORING
Track only the authorities and countries relevant to you — nothing else.
AI pre-categorization
Every regulatory update is automatically classified into the right category the moment it’s collected — no manual sorting required.
SECURE & TRACEABLE
FDA 21 CFR Part 11–compliant, with ISO 27001 and SOC 2 Type II–secured infrastructure.
Safety Database
Manage adverse events from intake to regulatory exchange in one compliant workflow.
AI-POWERED SIGNAL DETECTION
Identify potential safety signals and prioritize risk assessment.
ADVANCED REPORTING
Generate compliant reports and support deeper safety analysis.
E2B(R2/R3) SUPPORT
Exchange standardized safety data across regulatory systems.
AI-powered monitoring and expert-led workflows, keeping every safety decision in your control.
ADDITIONAL CAPABILITIES
MULTILINGUAL PROCESSING
Process local-language sources across 100+ languages without relying on separate manual translation workflows.
AI SUMMARIZATION
Turn long articles and regulatory updates into concise summaries with the key context, findings and outcomes.
ONE-CLICK ICSR
Create structured ICSR drafts from literature with one click, reducing manual case preparation.
From technology to hands-on PV support — choose the level of expertise your team needs.
PHARMACOVIGILANCE SERVICES
DrugCard combines multidisciplinary PV and regulatory expertise to support every stage of safety operations
LOCAL QPPV
SERVICES
Country-level pharmacovigilance oversight covering authority communication and safety intelligence.
24/7 regulatory contact point · Local signal escalation · RMP support · PSMF maintenance · PV audit & inspection support
SIGNAL DETECTION
& RISK OVERSIGHT
Structured signal management combining automated detection with expert clinical assessment.
Signal detection → Clinical assessment → Prioritization → Validation → Evaluation → Documentation & reporting
PSUR
& SAFETY REPORTING
Integrated periodic safety reporting based on validated safety data and compliant documentation.
PSUR/PBRER authoring · DSURs · RMPs · SOPs · PSMFs · SDEAs · Review & remediation · Submission support
ICSR
& CASE PROCESSING
End-to-end individual case processing from intake through validation and regulatory submission.
Intake & triage · AI-assisted data extraction · MedDRA coding · WHO Drug coding · QC & validation · E2B(R3) submission · Follow-up
PSMF
MANAGEMENT
Development, maintenance and remediation of the PSMF across its full lifecycle.
PSMF authoring · Annex maintenance · Gap assessment · Remediation · Continuous updates · Inspection-readiness support
LOCAL QPPV
SERVICES
Country-level pharmacovigilance oversight covering authority communication and safety intelligence.
24/7 regulatory contact point · Local signal escalation · RMP support · PSMF maintenance · PV audit & inspection support
SIGNAL DETECTION
& RISK OVERSIGHT
Structured signal management combining automated detection with expert clinical assessment.
Signal detection → Clinical assessment → Prioritization → Validation → Evaluation → Documentation & reporting
PSUR
& SAFETY REPORTING
Integrated periodic safety reporting based on validated safety data and compliant documentation.
PSUR/PBRER authoring · DSURs · RMPs · SOPs · PSMFs · SDEAs · Review & remediation · Submission support
ICSR
& CASE PROCESSING
End-to-end individual case processing from intake through validation and regulatory submission.
Intake & triage · AI-assisted data extraction · MedDRA coding · WHO Drug coding · QC & validation · E2B(R3) submission · Follow-up
PSMF
MANAGEMENT
Development, maintenance and remediation of the PSMF across its full lifecycle.
PSMF authoring · Annex maintenance · Gap assessment · Remediation · Continuous updates · Inspection-readiness support
Built by pharmacovigilance experts, powered by AI, trusted by teams like yours.
FROM SETUP TO CONTINUOUS SUPPORT
DrugCard adapts to your internal workflows, quality requirements and operational setup from day one.
ONBOARDING & IMPLEMENTATION
User Scope Definition · Initial PV Training · User Account Setup · GxP Traceability
AUDIT & COMPLIANCE REVIEWS
Internal PV Audits · Vendor & Partner Audits · GVP/ICH Compliance Reviews · CAPA Development
CONTINUOUS PV SUPPORT
SOP Templates · Validation Documentation · Post-Implementation Review
+ SPECIALIZED PV SERVICES
Retrospective searches · Reference product monitoring · Medical writing · Regulatory documentation support · Risk management · Focused literature & regulatory monitoring · PV Training & Consultancy
Strong PV operations start with expertise at the leadership level.
OUR MANAGEMENT TEAM
Dmytro Horilyk
Chief Executive Officer
Defines the company’s strategic direction, oversees business operations, and drives DrugCard’s growth across international markets.
Artem Horilyk
Chief Product Officer
Leads product strategy and development, translating PV requirements, automation, and AI into practical customer solutions.
Myroslav Demchun
Chief Technology Officer
Oversees the technology strategy and platform development, ensuring scalability, reliability, and security of all solutions.
Dmytro Horilyk
Chief Executive Officer
Defines the company’s strategic direction, oversees business operations, and drives DrugCard’s growth across international markets.
Artem Horilyk
Chief Product Officer
Leads product strategy and development, translating PV requirements, automation, and AI into practical customer solutions.
Myroslav Demchun
Chief Technology Officer
Oversees the technology strategy and platform development, ensuring scalability, reliability, and security of all solutions.
AI-powered monitoring, expert-led execution – full-service PV support end to end.
SHAPING THE PV COMMUNITY
Always staying close to industry developments — exchanging knowledge and contributing our own perspective.
We’re regulars at leading industry conferences, and twice now, we’ve hosted our own — Kyiv Drug Safety Day I & II — bringing the PV community together to exchange knowledge on regulations, automation, and compliance.
TRUST & RECOGNITION
- EUCROF Associate Member
- ISO 9001 Certified QMS
- AWS infrastructure / ISO 27001-certified data centers
- EU Annex 11 / GxP-aligned system
STAY AHEAD OF
PV COMPLEXITY
AI-powered monitoring and expert-led workflows, keeping every safety decision in your control.
