Here at Orphan Drug Consulting, our experienced team recognize the specific opportunities that arise for Orphan Drugs and niche products due to patients’ urgent need for these products.
Product Launch & Expanded Access Programmes (EAP)
End-to-end product launch strategy design and implementation via multiple pathways including Expanded Access Programmes (EAP) in over 100 countries around the world adopting a cross-functional strategic approach.
Due to the differing and country-specific requirements per region, our understanding of what it takes from a Compliance, Supply Chain and Regulatory perspective within these local markets can support you in not only launching these programs quickly but will also help you embed the correct supply strategies to smoothly transition these countries into commercial supply. We have launched products via multiple pathways in over 100 countries around the world. We understand the local requirements in each market and how to merge these requirements into your processes to ensure supply is available when reimbursement is agreed.
Key Strategy Impacts
- Local Market Supply Model Determination
- Optimum Route to Market Management
- Early Access/Named Patient/Managed Access Program Management
- Country-specific Launch Requirements e.g., ATU (France), Bollino (Italy)
- FMD/Serialization Management
- Brexit Support
- Compassionate Use Product Supply
- Cross Functional Launch Plan Management
- Clinical Product Management
- Local License Acquisition
- Country-specific Artwork and Packaging
- Local Partner Selection and Management
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