From Development Support to Regulatory Submission and Post-Market Support

We assist in product design and regulatory strategy development with differentiation from competing products in mind, to ensure smooth commercialization. In addition to a fixed monthly consultation fee, milestone-based billing is applied.

Our team consists of experienced professionals from major corporations.
We offer full-package support for those who may find it difficult to hire full-time employees.

• Advice for Regulatory Submissions and Approvals, and Infrastructure Development in Compliance with Various Regulations such as Public Health Laboratories

• Support for assay investigation and development for regulatory submissions

• Support for pilot study planning

• Support for performance evaluation study planning

• PMDA support (general consultation, face-to-face advice, application document preparation, response to inquiries)

• Support for preparation of health insurance reimbursement application and QMS conformity inspection

• Coordination of meetings with KOLs and support for marketing strategy development based on the developed product

• Support for post-marketing GVP compliance

• Business and market development support

Flexible Consultation Hours

We offer consultation services for up to a set number of hours per month, tailored to your budget. Billing is on an hourly basis.