Artixio

Pharmaceutical Consulting Company In Japan

Trusted pharmaceutical regulatory consulting firm in Japan helping with approvals, lifecycle management, and regulatory submissions.

End-to-End Regulatory Support
for Pharmaceutical Products in japan

Regulatory Affairs

Product Registration

IND (Investigational New Drug)

NDA (New Drug Application)

Technical Writing

Regulatory Strategy

Digital Marketing

Market Access

Regulatory Operations

Pharmaceutical Services For Global Regulatory Compliance

Expanding into Japan’s pharmaceutical market takes more than a solid product—it takes a clear understanding of how local systems work. At Artixio, we support pharmaceutical companies through the ins and outs of Japan’s regulatory process.

Some clients come to us before they’ve made their first move in Japan. Others already have products approved and want to stay aligned with evolving requirements. In both cases, we stay close to the process—helping early, staying involved, and stepping in when things stall or shift. It’s not about handing over a checklist. It’s about showing up when decisions need to be made.

Japan’s regulatory environment doesn’t follow the same playbook as other countries. What works elsewhere can easily be flagged here. We pay attention to those differences and adapt accordingly.

With hands-on experience dealing with PMDA and MHLW, we support everything from submissions and approvals to renewals and safety updates. For us, it’s not just about getting through the paperwork—it’s about getting it right, the first time.

FAQS About Pharma Regulatory in Japan

1. What kind of support can Artixio provide for pharmaceutical companies in Japan?

We help with everything from planning your entry strategy to handling product registrations, coordinating with health authorities, managing post-approval requirements, and more. Our support is end-to-end, based on where you are in your journey.

Yes, absolutely. We work with companies at all stages—whether you’re just starting out or already operating in Japan. We help you understand the local system, prepare the right documents, and avoid early missteps.

We bring both global experience and local insight. Our team understands how to adapt—not just translate—strategies to fit Japan’s system. We stay involved throughout, not just at the submission stage.

Yes. We often work alongside local partners—either advising in the background or taking on specific roles, depending on your setup. We’re flexible and can fill in wherever there’s a gap.

Why Choose Artixio For pharma consulting in Japan?

Experienced with Japan MAH coordination

Hands-on support, not just advice

Familiar with PMDA expectations, and review patterns.

We understand how Japan's system works — beyond what's written in the guidelines.

Help you avoid back-and-forth with clear, well-prepared submissions.

Regulatory Expertise Across
Multiple Countries

India
Vietnam
Mexico​

United States

Brazil

European Union

Industries we serve

Pharmaceuticals

Cosmetics

Nutrition

Medtech

Biologics

Veterinary

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