Evnia ApS: A Biotechnology Market Access through Regulatory and Clinical Affairs Excellence
Evnia ApS is a Danish biotechnology regulatory & clinical affairs leader expert in market access strategy and implementation. With a global client base of over 270 manufacturers, Evnia has earned a reputation for excellence in navigating complex regulatory frameworks and accelerating safe, compliant access to international markets.
Evnia’s services span the entire product lifecycle, from early development to post-market surveillance (from Lab to Market and beyond. The company has successfully attained hundreds of EU/MDR CE markings and FDA approvals through its groundwork in regulatory and clinical affairs. Its integrated approach ensures that clinical data generation is aligned with regulatory strategy, optimizing both compliance and product performance at an efficient time and cost outcome.
A key differentiator is Evnia’s vertically integrated infrastructure, including Evnia Clinical Network, which enables direct execution of PMCF studies and clinical investigations. This capability allows for tailored, scalable solutions that reduce operational complexity and improve time-to-market for biotech innovators.
Evnia also serves as an EU Authorised Representative and UK Responsible Person, helping international manufacturers maintain regulatory continuity and audit readiness across jurisdictions, especially in the post-Brexit landscape.
Beyond market access, Evnia operates has its own investment arm via the ARETI Saudi Bioaccelerator Fund, supporting biotech ventures and fostering innovation across borders.
Guided by the Greek principle of filotimo—a deep-rooted commitment to integrity, excellence, and societal impact—Evnia is more than a service provider. It is a strategic partner that transforms regulatory and clinical affairs into a competitive advantage, helping clients deliver safer, more effective biotechnology solutions to patients worldwide.