Who We Are

ProductLife Japan KK is the Japanese subsidiary of ProductLife Group (PLG), dedicated to supporting pharmaceutical, biotechnology, and medical device companies in Japan.

The new office officially opened on 4 September 2025, marking an important step in strengthening PLG’s presence across the Asia-Pacific region.

Our mission is to provide clients with specialized regulatory affairs and safety expertise in Japan, backed by a global network operating in more than 150 countries. With a bilingual team (Japanese and English) and deep understanding of the PMDA regulatory framework, PLG Japan bridges local compliance requirements with international best practices.

Our Focus

At PLG Japan, we focus on Regulatory Affairs, Safety & Vigilance and Market Access services, enabling Life Sciences companies to successfully navigate the Japanese market.

As of 2025, the office’s initial areas of expertise include:

  • Patient safety strategy and consulting services
  • QPPV & Local Safety Officer services
  • Pharmacovigilance case processing and local filing/reporting
  • Medical & technical writing
  • Regulatory strategy, submissions and lifecycle maintenance
  • PMDA consultation and services
  • MHLW pricing and access services
  • HTA dossiers

Services

Safety & Vigilance:

  • Pharmacovigilance case processing & local reporting
  • Signal detection & literature surveillance
  • Medical technical writing
  • Patient safety strategy, QPPV & LSO services

Regulatory Affairs:

  • Regulatory & development strategy tailored to Japanese regulations
  • J-NDA submissions and new product registrations
  • PMDA consulting and access services
  • Clinical trial approvals
  • Lifecycle maintenance & compliance

Market Access:

  • MHLW pricing and access services
  • Preparation of HTA dossiers
  • Economic modelling
  • Publication support

Why Partner with PLG Japan

  • Strategic pricing: Optimise price for local and international launches
  • Local expertise: in-depth knowledge of Japanese regulatory authorities and requirements
  • PMDA consulting: support for submissions, approvals, and interactions with regulators
  • Pharmacovigilance hub: end-to-end safety and vigilance services in Japan
  • Global reach: access to PLG’s international network spanning 150+ countries
  • Flexible models: consulting and outsourcing tailored to client needs

Our Role in JAPAC

Japan is one of the most mature and highly regulated Life Sciences markets in Asia-Pacific. With PLG Japan, we provide a central hub for regulatory, safety and market access services in the JAPAC region, supporting clients across both mature markets (Japan, South Korea, Australia, New Zealand, Singapore) and emerging markets (Philippines, Indonesia, Thailand, Vietnam, and beyond).

This new office builds on the strong Commercial Eyes foundation in JAPAC, and by combining local regulatory expertise in Japan with regional collaboration and insights, PLG helps Life Sciences companies accelerate patient access to safe and effective therapies.

Read the Japan Office Opening Press Release

Contact us

Tokyo Office:
GranTokyo South Tower 11 F
(Just Co)
1-9-2 Marunouchi
Chiyoda-ku
Tokyo 100-6611
Japan

Contact PLG Japan