Regulatory Consultation

We’re ready to provide high-quality regulatory consultation at any point in your pharmaceutical or medical device product’s journey to the Japanese market.

With our earned expertise of the Japanese pharmaceutical industry and market and a complete understanding of what it takes to meet Japan’s regulatory standards, we’ll provide a consultation approach that enhances your activities. Here’s how we do it.


Consultation built for Japan’s Pharmaceuticals and Medical Devices Agency

In Japan, the PMDA (Pharmaceuticals and Medical Devices Agency) is charged with ensuring the quality, efficacy, and safety of pharmaceutical and medical device products seeking entry in the national market, whether domestic or international in source. At IDEC, we provide a consultation approach built with the PMDA’s standards in mind, ensuring the J-NDA applications we prepare and submit for our clients are ready for the scrutiny of the organization.

It starts with the development strategy we formalize at the onset of our engagement. With that strategy, we build a consultation approach and materials that consider the needs of the future application. We ensure our strategy is tailored to the current trends of the PDMA, and we’ll create a consultation plan as we communicate with the organization. We’ll ensure their inquiries are addressed as they happen, and you’ll have a constant representative in all face-to-face meetings.

Japan Pmda Consultation
Regulatory Consultation Experience

No matter your need—we’ve been there

We’ve worked with clients at all stages of product development and Japanese market readiness. That means IDEC has experienced some common cases and questions along the way. Consider these common problematic scenarios:

  • Last time, you worked with an inexperienced subcontractor and failed to secure approval.
  • You want to connect with the PMDA, but you don’t know how to get started.
  • You lack the in-house specialists capable of preparing consultation materials and responding to Japanese regulatory inquiries.
  • You’re ready to work with organizations in Japan, but you lack the linguistic expertise to navigate the partnerships confidently.

We’ve seen it all, and we’re ready to help.

Build a Regulatory Consultation strategy that works.

Are you ready to begin?

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