Consultancy Support

Providing specialised consultancy services for biotech, Narla bio offers tailored expertise to address the intricate challenges associated with orphan drug development and distribution. For example, families impacted by rare diseases find solace in the potential improvement in their quality of life through these innovative pharmaceuticals. However, the complex process of introducing orphan drugs to new markets, particularly in Europe with its multiple countries, requires careful navigation.

Launching orphan drugs, crafted for conditions affecting fewer than one in 2,000 people, presents unique hurdles. The financial feasibility of addressing the European market complexities is complicated by the high value/low volume nature of orphan drug supply. Access and regulation complexities, with the European Medicines Agency (EMA) overseeing approvals while individual countries maintain autonomy in guidelines and reimbursement negotiations, further intensify the challenges.

The logistical considerations introduce additional layers of complexity, with diverse transport modes and the need for temperature control. Understanding the entire process is crucial to avoiding delays in drug delivery that could compromise stock integrity and deprive patients of timely treatment.

Reimbursement policies diverge across Europe, reflecting distinct healthcare systems and negotiation processes in each country. Disparities in the percentages of authorised orphan drugs funded by healthcare systems and the duration of reimbursement decisions highlight the need for a nuanced approach.

To surmount these challenges, we recommend collaboration with our experienced consultants specialising in orphan drug supply. A reputable partner can establish a comprehensive supply chain and clinical network spanning the continent, addressing not only physical logistics but also regulatory compliance, import licenses, customer service, and storage and delivery management.

Late-stage customisation emerges as a strategic solution, allowing products to be stored centrally in Europe and customised for specific countries without committing to large volumes. This method ensures compliance with diverse regulatory requirements, such as language translations and country-specific information.

In summary, our biotech consultancy service is designed to guide and support clients through the intricate landscape of orphan drug development and distribution, offering strategic insights and solutions tailored to the unique challenges in this field.