Pharmaceutical Business Consulting

H. Holstein partners with domestic and international pharmaceutical companies to deliver end-to-end support for entering the Japanese market, from strategic planning to execution, including market entry strategy, partnership and licensing advisory, and regulatory affairs support.

Turning Global Innovation into Japan Market Reality

Japan is not just another market. Success requires alignment across business development, regulatory expectations, and partner strategy. We help bridge these elements.

What We Do

We act as a Japan-focused strategic partner across key stages of market entry:

  • Licensing & Partnering Strategy

    Identification, positioning, and negotiation with the right Japanese partners

  • Japan Market Entry & Regulatory Strategy

    Structuring regulatory pathways aligned with Japan-specific requirements

  • Alliance & Execution Support

    Facilitating coordination between global companies and Japanese partners

  • Japan Liaison Function

    Local interface for companies without a presence in Japan

Why H. Holstein

  • Integrated Deal & Regulatory Perspective

    We bridge business development and regulatory strategy: Licensing and regulatory considerations are aligned from the outset to support realistic and executable strategies

  • Japan-Centric, Execution-Aware Approach

    We translate global plans into approaches that work within Japan’s regulatory and business environment

  • Focused Role in Execution

    We provide advisory and coordination support, with targeted hands-on involvement in areas such as Drug Master File (MF) registrations and Foreign Manufacturer Accreditations (FMA) related processes

  • Cross-Border Bridging

    We facilitate alignment between global companies and Japanese partners across cultural and operational differences

Regulatory Strategy for Japan

We design regulatory approaches tailored to Japan’s requirements, including:
  • Regulatory risk assessment and mitigation
  • Bridging strategies and Japan-specific clinical considerations
  • PMDA engagement support
  • Alignment of global development plans with Japan requirements
Where appropriate, we provide targeted operational support for MF and FMA-related filings.

Your Partner for Japan

H. Holstein combines strategic insight with practical understanding of how Japan works—helping global companies move from opportunity to execution with the right partners and approach.