Services

PMDA consultation is a critical first step in helping the authority understand your device. Based on your regulatory data, we develop the meeting strategy: general meeting, prior development meeting, protocol meeting, and, pre-clinical trial meeting.

SaMD used in Japan must comply with Japan cybersecurity standard (JIS-T-81001) and related regulatory requirements. We help customize the cybersecurity regulatory documents attached to the MAA dossier.

We help customize the MAA (Marketing Authorization Application) documents​

and STED (Summary of Technical Documents) based on your foreign regulatory data.​ A gap analysis is available if you have completed the STED for another country submission.

QMS (Quality Management System) Conformity Audit by PMDA is required after submitting the MAA dossier. We provide the GAP analysis between Japan QMS requirements (QMS省令) and foreign QMS and help prepare the conformity documents.