As rare disease companies continue to face the challenge of entering new markets without adequate infrastructure build and knowhow, Orphan Drug Consulting experts recently supported one such company with an accelerated launch into the EU market.

Using its cross-functional team and proven approach, Orphan Drug Consulting enabled early access of the client’s treatment to patients and successful commercial launch.

Orphan Drug Consulting provided a comprehensive and detailed route to market, including:

  • A full operational review of the client’s strategy, including mapping out desired supply pathways, entity structures and IP location
  • Regional and country gap analysis ensuring compliance with relevant regulations, licencing, entity and tax structuring
  • Workstream deep-dive to determine prioritisation and risk mitigation plan
  • Detailed roadmap with recommendations including optimal distribution model, licencing requirements, import VAT and customs considerations and early access programme (EAP) strategy

As a result, the biotech decided to enter the European market, choosing an appropriate entity structure, a centralised distribution hub with a direct product supply to pharmacy and hospitals. An important consideration for this was to keep infrastructure light, focusing on commercial entities and stabilising the quality management system, third party logistics and budgeting costs for entering the new market.

With the help of Orphan Drug Consulting, the company successfully launched into the European market, prioritising key countries. Through the partnership, simplified solutions were adopted to achieve targeted milestones. These accomplishments included establishing a robust budget for market entry, defining a suitable entity structure, and ensuring regulatory compliance throughout technical operations. Other success included optimized efficiency in product delivery, streamlined vendor selection processes, and enablement of an organisational build with focus on global, regional and country roles. Orphan Drug Consulting’s efforts ensured the client’s successful launch and operational readiness.

To explore how Orphan Drug Consulting can elevate your product supply strategy for both clinical and commercial assets, reach out to our dedicated experts

Let us help you redefine success in the ever-evolving orphan drug landscape and unlock the full potential of your biotech endeavours.

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