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Daini Yanagiya Bldg. 1-12-8 Nihonbashi, Chuo-ku

Tokyo 103-0027  Japan  

© 2019 Vorpal Technologies K. K.​

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...

  • Patient Population Definition

  • KOL Identification & Influencing

  • Treatment Landscape Clarification

  • Product Evaluation

  • Pricing Assessment

  • Opportunity Sizing

Opportunity Validation

  • 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

Regulatory Development

  • QMS Development & Maintenance

  • Designated Marketing Authorization Holder (D-MAH) Services

  • Importation & Market Release

  • Labeling & Repackaging

  • Warehousing & Logistics

Quality & Operations

  • Clinical Trial Design

  • KOL Engagement & Site Selection

  • Clinical Operations & CRO Management

  • GCP Compliance Assessments

  • Post-Marketing Surveillance (PMS)

  • Clinical Research Support

Clinical Development

  • Reimbursement Strategy Formulation

  • Medical Society Engagement

  • Patient Group Engagement

  • Treatment Guideline Influencing

  • MHLW Engagement

  • HTA & Health Economic Analysis

  • Q&A to Acceptance

Reimbursement

  • 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

Commercial Develpment