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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...


Regulatory Development

  • Product Evaluation and Market Research

  • Regulatory Strategy Formulation

  • PMDA& MHLW Engagement

  • KOL & Medical Society Engagement

  • Support for the formulation of Appropriate Usage Guidelines

  • Regulatory File Development & Submission

  • Q&A to Approval

  • GCP Compliance Assessments

  • Post-Marketing Surveillance (PMS)

Reliability Assurance & Operations

  • Support of Foreign Manufacturer Registration (FMR)

  • QMS Submission

  • Designated Marketing Authorization Holder (D-MAH) Services

    • QMS Development & Maintenance

    • Importation & Market Release

    • Inspection, Labeling & Repackaging

    • Safety Report Management 


  • Reimbursement Strategy Formulation

  • Medical Society Engagement

  • MHLW Engagement

  • HTA & Health Economic Analysis

  • Reimbursement Apprication Form Development & Submission

  • Q&A to Acceptance

Support for
U.S. Market Entry

  • The parent company of Vorpal is the MCRA, a leading consulting firm in the fields of regulatory affairs, clinical affairs, and reimbursement, headquartered in Washington, D.C., USA. It is a full-service Contract Research Organization (CRO) with three offices in the United States and one office in Europe. Vorpal will support the expansion into the global MedTech industry through MCRA.

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