ProductLife Group in Japan
Regulatory Affairs & Safety Expertise in Japan, connected to a global Life Sciences network.
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 and Safety & Vigilance 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 access services
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
Why Partner with PLG Japan
- 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 and safety services in the JAPAC region, supporting clients across both mature markets (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, PLG helps Life Sciences companies accelerate patient access to safe and effective therapies.