Vorpal Approach

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Vorpal is a unique platform offering

virtual subsidiary services in Japan for international MedTech innovators

Vorpal offers expertise in market assessment, clinical, regulatory and reimbursement services, enabling companies to successfully enter Japan with their approvals under their own control.

Vorpal offers importation, warehousing and distribution infrastructure to offer a unique virtual subsidiary platform for overseas MedTech companies wishing to sell in Japan without investing in their own direct organization.

Vorpal offers end-to-end solutions for success in Japan...

Opportunity Validation

Patient Population Definition
KOL Identification & Influencing
Treatment Landscape Clarification
Product Evaluation
Pricing Assessment
Opportunity Sizing

Regulatory Development

Regulatory Strategy Formulation
PMDA& MHLW Engagement
KOL & Medical Society Engagement
High Medical Needs & HBD Program Involvement
Orphan Designation
Regulatory File Submission
Q&A to Approval

Quality & Operations

QMS Development & Maintenance
Designated Marketing Authorization Holder (D-MAH) Services
Importation & Market Release
Labeling & Repackaging
Warehousing & Logistics

Clinical Development

Clinical Trial Design
KOL Engagement & Site Selection
Clinical Operations & CRO Management
GCP Compliance Assessments
Post-Marketing Surveillance (PMS)
Clinical Research Support

Reimbursement

Reimbursement Strategy Formulation
Medical Society Engagement
Patient Group Engagement
Treatment Guideline Influencing
MHLW Engagement
HTA & Health Economic Analysis
Q&A to Acceptance

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