Expert regulatory intelligence and pharmacovigilance support for the Hungarian market
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Regulatory Intelligence
Stay ahead of Hungarian regulatory changes with our comprehensive monitoring and analysis services.
- Real-time monitoring of NNGYK/OGYÉI updates
- NEAK reimbursement policy tracking
- Regulatory impact assessments
- Translated summaries in English
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Regulatory Affairs – PV Support
Safety-related regulatory documentation and submission support.
- Product information (SmPC, PIL, labelling)
- Clinical safety summaries
- Risk Management Plans (RMP) preparation
- Safety-related variations
- CTD safety modules (1.8.1, 2.5, 2.7.4)
- PSUR/PBRER preparation
- Support during registration procedures
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Full Registration Dossier Support
Complete regulatory submission services for the Hungarian market.
- CTD dossier compilation
- Translation & localization into Hungarian
- Submission via CESP / eSubmission gateway
- Lifecycle management (variations, renewals)
- Line extensions
- Regulatory correspondence with authorities
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Product Information & Translation
Professional translation and localization services for pharmaceutical documentation.
- SmPC/PIL/labeling translation
- Safety-related updates and alignment
- Mock-up review
- Readability compliance checks
- Hungarian regulatory format compliance
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Strategic PV & RA Consulting
Expert guidance for pharmacovigilance and regulatory strategy.
- PV system design strategy
- Global PV expansion & affiliate setup
- Advice for small/startup MAHs entering EU
- PV-RA interface consulting
- Risk minimization strategy support
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QPPV & Local Safety Responsible Services
EU/EEA QPPV and Local Person Responsible for Pharmacovigilance (LPPV/LSRP) services for Hungary.
- EU/EEA QPPV services
- Local PV Responsible for Hungary
- Backup QPPV / Deputy QPPV services
- PV system establishment & oversight
- Safety governance & compliance control
- QPPV oversight statements & audits
- CAPA follow-up
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Market Access Consulting
Navigate the Hungarian reimbursement landscape with expert guidance.
- HTA dossier preparation
- Pricing and reimbursement strategy
- NEAK submission support
- Stakeholder engagement
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PV System Setup & Maintenance
Complete pharmacovigilance system infrastructure for MAHs and distributors.
- Full PV system setup
- PSMF creation, upgrade & maintenance
- PV agreements (SDEAs) creation
- Safety database implementation
- Literature monitoring (local & global)
- 24/7 case intake service with SLA
- PV SOP writing & updates
- PV KPI frameworks & dashboards
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Case Management Services
Comprehensive adverse event case processing and reporting services.
- 24/7 case receipt and triage
- Case logging, validation & duplicate check
- Medical assessment of cases
- Safety database entry and QC
- E2B transmission to authorities
- Follow-up management
- Serious and non-serious ICSRs handling
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Medical Information & Enquiry Handling
Professional medical information services with PV integration.
- Medical information service
- Recording & classification of MI enquiries
- Scientific response creation
- PV triage for MI questions
- Integration with safety inbox
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Audit, Compliance & Quality Services
Ensure your operations meet Hungarian and EU regulatory standards.
- PV audit (internal or supplier)
- PV system gap analysis
- GVP compliance monitoring
- CAPA planning & implementation
- Mock inspections
- Inspection management support
- Periodic quality system review
- Risk-based internal reviews
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Due Diligence
Comprehensive regulatory assessments for business decisions.
- Regulatory status reviews
- Portfolio assessments
- Risk analysis
- Market entry feasibility
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Training & Education
Build your team's expertise in pharmacovigilance and Hungarian regulatory affairs.
- Customized PV training for companies
- QPPV/LPPV onboarding programs
- PV inspection readiness training
- Signal management workshops
- Case processing training
- Hungarian regulatory landscape
- Market access strategies
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Labeling & Notification Services
Complete regulatory support for food supplements, cosmetics, and medical devices in Hungary.
- Translation of labels (ENG → HU)
- Ingredient assessment & compliance review
- Product notification and registration
- Medical devices (Class I, IIa, IIb)
- Food supplements & cosmetics
- Distributor registration
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Medical Device Regulatory
End-to-end regulatory support for medical devices in Hungary and EU markets.
- MDR/IVDR compliance strategy
- Technical documentation preparation
- Clinical evaluation reports
- Post-market surveillance systems
- Notified Body liaison
- Hungarian market authorization
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Medical Writing
High-quality regulatory and scientific writing services for pharmaceutical and medical device industries.
- Clinical study reports (CSRs)
- Investigator brochures
- Clinical trial protocols
- Regulatory submission documents
- Scientific publications
- Patient information materials
