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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. 

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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 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

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