Kaye Suzuki Device Consulting, LLC
Kaye Suzuki Device Consulting, LLC
600 First Avenue
Suite 600
Seattle, WA 98104
ph: 360-356-1177
info
OUR SERVICES
No matter where you are in the product development, marketing, regulatory compliance or production phase, our experience with integrated quality systems can help you accelerate and optimize your business plan. Our specific areas of consulting expertise include:
New Market Development
We will work with your business development team to develop a comprehensive Japan market entry strategy with practical plans that include key milestones to make your plan a reality. We will coach each step of the execution. This is the first step to be success in Japan. The following services are presented in the sequence we recommend for the smoothest and least burdensome entry into the Japanese market.Product Development
We will teach your product development team to understand the Japan regulator's expectations on design inputs, and verification and validation testing that will ensure you will not need to re-develop the product when applying for Market Release Approval (Shonin) for Japan. The sooner you start this process the sooner we can chart and begin managing your regulatory roadmap.Regulatory Approvals
We will work with your regulatory and clinical team on effective regulatory strategy. Our goal is to prevent the need for a clinical trial in Japan by identifying and leveraging the clinical data obtained in other countries. Next, we will teach your team how to develop the Market Release Approval (Shonin) Application and STED, Foreign Manufactuer Accreditation Application, all in English to ensure that you know what you are applying for. We will also work with your team through the review process, GCP audit and QMS audit until approval.
Reimbursement
We will teach your reibursement team the most effective and profitable reimbursement strategy for your new device and/or therapy. Then we will teach your team how to develop the National Health Insurance Reimbursement Request Form in English to ensure that you know what you are applying for. We will also work with your team through the process until you gain appropriate reimbursement.Post Approval Compliance
We will teach your quality, vigilance and compliance team how to keep the product on the market after approval while fully complying to PAL, GVP, GQP, GPSP, QMS and other relevant laws and regulations in Japan including ethic code. We will work with your team to modify your processes to meet those requirements and expectations. We will also work with your team through the reporting process and field action, if necessary. We will be working with you for dispute resolution, the opportunity to show the corporate integrity. The key is to be open and patient oriented to manage the real life challenges.General Management
We will teach your executive management team practical strategies and methods for doing business in Japan. Probably not the conventional way but more of a new approach. We will work to find the best approach for your organization based on your values and beliefs. There is no such thing as an uniform Japanese way to do business, other than those stipulated in the laws, just as there is no such thing as a US way. There should only be one way for each company. Respecting the local culture is important, but should not compromise the corporate philosophy for it.
Doing businesses in Japan is sometimes cumbersome or confusing for western businesses. We are here to guide you on your journey. The sooner you understand the Japanese business and regulatory landscape, the more likely you will be to success.
Kaye Suzuki Device Consulting, LLC
600 First Avenue
Suite 600
Seattle, WA 98104
ph: 360-356-1177
info
