Life Sciences Horizons Brochure 2025 - Flipbook - Page 32
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2025 Horizons Life Sciences and Health Care
Radioactive material licensing compliance concerns
Nuclear and radioactive materials play a critical role
in modern medicine for many types of diagnostics and
treatments. As demand for precision medicine grows,
so does the need for health care companies to
integrate nuclear capabilities. We are seeing it
happen; companies in this space are actively
developing medical isotope manufacturing
capabilities, leveraging nuclear and radioactive
materials infrastructure, and addressing shortages
of isotopes essential for diagnostics, therapies,
and medical innovation.
Although nuclear regulatory approval concerns often come to
light during M&A activity, companies in the radiopharmaceutical
space should also assess their compliance when bringing new
drug treatments to market. For example, current nuclear reactor
companies and universities with research reactors should think
strategically about the production and sale of medical isotopes
and emerging nuclear medicine technologies in order to
ensure compliance with nuclear and pharmaceutical
regulatory requirements.
Whether it’s evaluating production capabilities or identifying
market opportunities, aligning technical innovation with
regulatory and commercial strategies is critical to navigate the
evolving landscape of nuclear medicine, while maintaining the
highest standards of safety and compliance. We are also seeing
companies in the radiopharmaceutical space around the world
facing novel issues involving nuclear regulatory distribution
compliance, contracting concerns, and international distribution
and supply chains issues, noncompliance for which often comes
with the risk of sanctions.
Amy Roma
Partner
Washington, D.C.
Stephanie Fishman
Senior Associate
Washington, D.C.
