Hogan Lovells Digital Health brochure 2024 - Flipbook - Page 14
Hogan Lovells
Product advisory and
regulatory pathways
Innovating and bringing new digital
health products and services to
market requires addressing a host
of issues: regulatory approval,
patents, financing, manufacturing,
distribution, and more. After your
product debuts, the challenges
continue throughout its lifecycle,
from running compliance
programs to responding to
enforcement actions.
We routinely assist clients in getting their
products tested and approved. Our 昀椀rm
stands out among major international
law 昀椀rms in combining its regulatory and
commercial experience into one single,
integrated team. We assist with clinical
trial design and operations, early access
programs, marketing approval, GMPs,
importation, pharmacovigilance, and the
many other regulatory issues that arise
during product development. Integral to our
regulatory practice is a deep understanding
of all forms of regulatory exclusivity, as
well as the intersection between regulatory
exclusivity and patent protection.
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