Capture Japanese market
with your own
regulatory strategy
and tactics.

Engage deep market expertise.
Accelerate toward global simultaneous approval.
Optimize your workload and development costs.

The utilization of a well-crafted regulatory strategy and tactics
can significantly expedite development progress, reduce
workload, and minimize development costs.

Consulting with us and investing time before proceeding with your
development activities in Japan can serve as a valuable shortcut.
Leveraging our experience and knowledge will enhance the
probability of success in navigating the regulatory landscape.

Form a partnership that accelerates your global path to market.

We proudly offer regionally specialized regulatory guidance, expertise, and complete drug product support for innovators seeking approval in Japan, the third-largest pharmaceutical market in the world.

See Our Services

We pair deep regional expertise in Japan with a holistic, global mindset.

We are committed to your success at every stage, from strategy to approval and beyond.

We provide an indispensable Virtual R&D Team to add value to every interaction.

We are part of a global delivery network that enables you to take one path to market that satisfies regional regulatory realities.

We’re part of the Validant family of companies, a global network that provides unrivaled access to full-lifecycle support.

Meet the Validant Family

Discover our intuitive, step-by-step process.

We believe the best approach to entering the Japanese market is developing your product with global regulatory standards in mind from the very start. Here’s how we do it.