We provide actionable insights to support strategic decision-making in rare disease markets:
- Epidemiology and patient identification
- Mapping regulatory and access pathways
- Reimbursement and pricing landscape analysis
- Standard of care and unmet needs identification
- Stakeholder and KOL mapping
- Patient advocacy and NGO landscape review
- Competitive intelligence
We support on-the-ground execution to enable early diagnosis, access, and awareness:
- Hospital mapping and segmentation
- Engagement with key clinical experts and centers of excellence
- Patient identification and diagnostic pathway support
- Early access program implementation
- Scientific exchange and medical education
- Collaboration with hospital pharmacists and administrators
- Support for treatment initiation and monitoring
- Local stakeholder engagement (incl. payers and NGOs)
- Real-world feedback and insight collection
We guide your product through the Polish reimbursement system, from strategy to implementation:
- Reimbursement pathway definition (e.g., drug program, RDTL, outpatient list)
- Full HTA dossier preparation (Core Value Dossier, economic model)
- Reimbursement application development and submission
- Engagement with AOTMiT during the HTA process
- Price negotiation with the Economic Commission
- Monitoring MoH decision-making
- National access implementation planning and coordination
We coordinate compliant and efficient local distribution in partnership with qualified providers:
- Coordination of demand forecasting and supply planning
- Product importation under MAH oversight and regulatory status
- Order handling from healthcare providers (e.g., RDTL, drug programs)
- Support for special access requests (e.g., compassionate use)
- Identification of local access barriers and operational needs
We ensure regulatory integrity and pharmacovigilance compliance throughout the product lifecycle:
- National registration and market access support
- Regulatory input for reimbursement processes
- Communication with local regulatory authorities
- Adverse event reporting and local case handling
- Compliance with EU QPPV and local PV frameworks
- Literature monitoring and signal detection
- Provision of safety data for HTA and reimbursement