When and how to start an asset clinical development in Japan?

Need for an affiliate company in Japan?

What would be the optimal development and regulatory strategy? Are there different options? Local development, bridging program or global program?

Is there a need for a P1 in Japanese?

What are the ways to shorten to time-to-market of an asset in Japan?

How to catch up with the EU/US developments?

Need for an in-country care taker? Which CROs to use? How to ensure that the clinical studies move on time, quality and costs?

When to consult Pmda? Unformal or formal meetings?

Who can help to write and file the NDA? To answer Pmda’s post-filing queries? To manage the GxP inspections?

Is there a need for a Risk Management Plan? How to conduct a Post-Marketing Surveillance?

A number of questions we can help you to answer.