Enter Japan with Clarity.
Execute with Confidence
Providing end-to-end support
for emerging overseas
biopharmaceutical companies
seeking to enter
the Japanese market,
from market entry assessment
to regulatory
approval to
post-marketing
distribution.
PATH-Solution is committed to helping improve access to innovative medicines in Japan by delivering them to patients as quickly as possible, safely and securely.
Through seamless, end-to-end support—from the early stage of considering entry into the Japanese market through commercialization—we work together with partners in Japan and overseas to contribute to addressing drug lag and loss and to advance the future of healthcare.
Shigeki Ohashi
Director, Vice President & Executive Officer
Challenges to entering
the Japanese market
-
How complex
are the
regulatory
requirements? -
How will we
build the
right execution
framework? -
What level
of investment
will
be
required? -
Which Japanese
partners should
we
collaborate
with?
Platform for
Accelerating Therapeutics in Healthcare
-
One unified platform supporting
you from entry
strategy to post-launch -
Comprehensive market research,
regulatory strategy,
and premium distribution planning -
Flexible,
tailored entry models
designed for each company
- *1HTA (Health Technology Assessment): A method for evaluating medical technologies when determining drug prices and insurance coverage
- *2ROI (Return on Investment): Investment return rate
- *3PMDA: Pharmaceuticals and Medical Devices Agency
- *4KOL (Key opinion leader): Influential experts or physicians in the medical field
- *5CMC (Chemistry, Manufacturing, and Control): Activities that comprehensively encompass chemical properties, manufacturing processes, and quality control in pharmaceutical development to ensure product safety, consistency, and quality
- *6GQP (Good Quality Practice): A quality management standard for manufacturing and marketing
- *7GVP (Good Vigilance Practice): A post-marketing safety management standard for pharmaceuticals and related products
- *8GDP (Good Distribution Practice): Basic guidelines to promote quality assurance in the distribution of pharmaceuticals
Enter Japan with Clarity.
Execute with Confidence
Let us meet at Bio !!
