We provides comprehensive solutions for your company to success your business in Japan
Package
Opportunity Validation
・Patient Population Definition
・KOL Identification & Influencing
・Treatment Landscape Clarification
・Product Evaluation
・Pricing Assessment
・Opportunity Sizing
Clinical Development
・Clinical Trial Design
・KOL Engagement & Site Selection
・Clinical Operations & CRO Management
・GCP Compliance Assessments
・Post-Marketing Surveillance (PMS)
・Clinical Research Support
Regulatory Affairs
・Regulatory Strategy Formulation
・PMDA& MHLW Engagement
・KOL & Medical Society Engagement
・High Medical Needs & HBD Program Involvement
・Regulatory Documentation
・Q&A response for Certification/Approval
Reimbursement
・Reimbursement Strategy Formulation
・Medical Society Engagement
・Patient Group Engagement
・Treatment Guideline Influencing
・MHLW Engagement
・HTA & Health Economic Analysis
・Q&A response for Acceptance
Quality & Operations
・QMS Conformity Survey
・MAH/DMAH Services
・Importation & Market Release
・Labeling & Repackaging
・Warehousing & Logistics
・Safety management & Reporting of defects
Commercial Develpment
・Marketing & Business Strategy Development
・KOL & Rising KOL Engagement
・Advisory Board Establishment
・Congress Strategy & Implementation
・Clinical Education Program Development
・Clinical Research & Publication Support
・Distribution Partner Selection & Engagement
Regulatory affairs consulting that enables foreign MedTech company to enter the Japanese market on their own initiative
・Establishment of three roles of "General Marketing Manager," "Domestic Quality Control Manager," and "Safety Control Manager" (Personnel who meet the qualification requirements are required for each position)
・Preparation and retention of documents and records (5 years and or 15 years retention) (QMS and GVP management)
・QMS surveillance every year (renewal audit)
・Periodic QMS conformity survey every 5 years
・Keeping work and storage space (for product identification and inventory) for inspection
・Labor costs for the three functions and workers, as well as maintenance costs for the location
Regulatory affairs consulting
1. Registration consulting (project management)
2. Preparation of documents for certification/approval applications
3. Preparation of documents included in STED
4. Preparation of documents for QMS compliance inspections
5. Preparation of agreements
etc.
* We will listen to your request and make a proposal customized to your company.
(Optional) MAH, DMAH
1. Overall manufacturing and sales operations
・Quality control operations based on the QMS Ministerial Ordinance
・Post-marketing safety management operations based on the GVP Ministerial Ordinance
・(Manufacturing operations) product import, storage, shipping inspection and distribution management
* The license fee is calculated as one set per product (e.g. four products = four sets of license fees), and the license fee is determined after consultation based on the nature of the product and the failure rate and annual shipment volume based on risk analysis.
Regulatory affairs consulting fee as Annual fee
(If needed) +MAH/DMAH license fee as Monthly fee
+Costs for receiving, inspecting, packaging, labeling, inserting package inserts, storing, inventory management, etc.
Please give us an overview of your products and business.
We will survey what we can do for you. If necessary, we will ask for more details in your products and business.
We will send you a quotation according to your request.
We welcome your inquiries by e-mail, anytime, 24 hours a day, 7 days a week. Please contact us anytime.
We can also respond to your concerns or problems over the video chat.