Rare diseases
Expansion into new international biotech markets can be challenging. Unfamiliar regulations and licensing, coupled with language and cultural differences, can all be barriers to growth. If you’re considering venturing into Europe and beyond, our easy-to-follow guides, shaped by 30 years of expertise in the rare disease market, will assist you in navigating challenges and gaining a profound understanding of the complexities involved in launching orphan drugs into new markets. To learn more about how Sciensus can facilitate and support your Europan expansion, visit: Rare Diseases and Orphan Drugs
Blogs, Rare diseases
Strategic timing: When should biotech firms consider launching expanded access programs?
Blogs, Rare diseases
How to set up an EAP without a European presence
Blogs, Rare diseases
EMA orphan drug designation
Blogs, Rare diseases
Four considerations before collecting real-world data in your EAP
Blogs, Rare diseases
The increasing importance of real-world data for the EMA
Blogs, Rare diseases
Six steps for a successful Expanded Access Program in Europe
Thought Leadership, Rare diseases
Navigating the transition from open label extensions to early access programs
Thought Leadership, Rare diseases
Leveraging Early Access Programs and Real-World Data for commercial success
Blogs, Rare diseases
Mitigating Risks in Early Access Programs: A Guide for Biotech Companies