Satoru Nagasaka

Practice Areas

Life Science, Healthcare, Digital Health, Pharmaceutical, Medical Device, Biotech, Health Food, Health Device, Regulatory Compliance, Research and Development, Joint Development with Academia, Clinical Trials, Product Development and Commercialization, Marketing Authorization, GxP Compliance, License Agreement, Distribution Agreement, Patent Infringement Litigation, Patent Prosecution and Strategy, Investigation of Fraud, Corruption and Inappropriate Accounting in Life Science Industry, Corporate Dispute Resolution, International Arbitration, Competition Law in Healthcare Sector, Data Privacy and Protection in Healthcare, AI and Digital Health Regulations, Medical Software Development, Telemedicine Regulations, Healthcare M&A, Venture Capital in Healthcare, Medical Device Certification, Pharmaceutical Supply Chain, Clinical Research Compliance, Healthcare Facility Regulations, Medical Professional Liability, Healthcare Industry Restructuring, Cross-border Healthcare Transactions, Healthcare Joint Ventures.

Career

TMI Associates (1994 - 2023)

Hughes Hubbard & Reed LLP, New York (2001 - 2002)

Professional Memberships

Admitted: Japan, 1994

Clients

-Major Japanese and non-Japanese manufacturers of pharmaceutical products, medical devices, diagnostic equipment, and health foods

-Global pharmaceutical companies and medical device manufacturers seeking to enter or expand in the Japanese market

-Japanese and non-Japanese venture businesses and start-ups in biotech, health device and digital health sectors

-Academic institutions and research organizations engaged in life science research and development

-Healthcare technology companies developing AI and digital solutions

-Medical institutions and healthcare providers

-Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs)

-Digital health platform providers and telemedicine service companies

-Medical device software developers

-Healthcare data analytics companies

-Pharmaceutical wholesalers and distributors

-Medical equipment leasing companies

-Healthcare investment funds and venture capital firms

-Medical professional associations and industry groups

-Healthcare consulting firms

Industry Sector Expertise

-Regulatory compliance and applications for marketing authorization of pharmaceuticals and medical devices

-Complex R&D-related contracts including joint research agreements with academia, clinical trial agreements, and material transfer agreements

-Comprehensive knowledge of Japanese healthcare laws, regulations and guidelines including GCP, GLP, GMP, GQP, GVP and GPSP

-Strategic patent protection and enforcement for pharmaceutical products, medical devices and bio products

-License agreements, technology transfer agreements, and distribution agreements in life science sector

-Quality assurance and safety reporting requirements for pharmaceutical products and medical devices

-Digital health regulations including AI medical devices and software as medical device (SaMD)

-Product liability and safety reporting in healthcare sector

-Healthcare data privacy and protection

-Anti-corruption compliance in healthcare industry

-Regulatory compliance for regenerative medicine and cell therapy products

-Clinical trial regulations and patient informed consent

-Healthcare pricing and reimbursement regulations

-Post-marketing surveillance and safety monitoring requirements

-Cross-border transactions and international collaborations in life science sector

-Medical device software development and validation requirements

-Telemedicine platform development and regulatory compliance

-Healthcare facility licensing and operational requirements

-Medical professional liability and risk management

-Healthcare joint venture structuring and documentation

-Pharmaceutical manufacturing and quality control regulations

-Healthcare data management and security requirements

-Medical device recall and corrective action procedures

-Healthcare facility acquisition and restructuring

-Pharmaceutical supply chain regulations and compliance

-Healthcare venture capital investment structuring

-Medical device distribution and import/export regulations

-Healthcare industry competition law compliance

-Cross-border healthcare data transfer regulations

-Healthcare intellectual property portfolio management

Expert in these Jurisdictions

Japan

Languages Spoken

Japanese and English

Education