Frequently Asked Questions (FAQs)

Q: How is this different from traditional consulting?

A: Our service is a "product" with a fixed scope, a fixed price, and a fixed timeline. We deliver a concrete strategic blueprint, not endless meetings. No surprises, no hidden costs.

Q: Do you handle the actual regulatory submissions to PMDA?

A: We provide the crucial strategic guidance for your submission and planning. For the administrative process of filing documents, we connect you with our network of trusted, specialized regulatory partners in Japan.

Q. What happens after the assessment?

A: The choice is yours. You can take the blueprint and implement it with your own team, or you can engage us for ongoing, hands-on support to execute the plan. There is no obligation.

Q: What exactly is the "Applicable Regulations Research" in the Full Assessment?

A: No, this Assessment is not a substitute for formal legal advice from a qualified A: It is an expert research and compilation service. Our role is not to provide a legal opinion or strategic interpretation of the regulations.

Instead, we perform the time-consuming task of researching and identifying the key laws, ordinances, and guidelines from the PMDA and MHLW that appear to be relevant to your specific product.

The deliverable is a clean, organized list of these essential regulatory documents. This document serves as a powerful starting point for your formal consultation with a qualified lawyer, saving your team dozens of hours of initial research.