Accelerate Your PMDA Pathway with Strategic Consultation Support

Secure approval faster with PMDA pre-submission meetings and briefing book expertise.

Let’s Discuss Your PMDA Consultation Strategy

Celebrating Customers Success

Why PMDA Consultations Are Critical to Success for Japan Drug Registration

Misalignment of clinical expectations

Delayed feedback → trial redesign

Approval risks if guidance isn’t secured early

PMDA Consultation Support – Full Lifecycle Services

Early-stage PMDA briefing document prep

Ensure a strong start with focused, high-impact briefing documents aligned with PMDA’s review standards.

Submission of Q&A and preliminary meeting materials

Present clear, strategic questions and data that drive focused and productive discussions.

Strategic alignment before J-NDA

Ensure your development plan is fully aligned with PMDA expectations well before submission.

Meeting coordination and representation

Leave the planning and participation to us; we manage everything from scheduling to in-meeting support.

Follow-up documentation and response strategies

Close the loop with well-prepared minutes, action items, and responses that keep your submission on track.

 
 
 

Success Stories

  • Freyr Provided Comprehensive Regulatory Support Accelerating Global Submissions and Ensuring Compliance for a Japanese Pharmaceutical and Biotechnology Company Across Multiple Markets

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  • Freyr Streamlined and Standardized Submission Processes for a Japanese Drug Manufacturer's Successful Market Entry into the US Market

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  • Freyr Provided Comprehensive Regulatory Support for Managing Partial Change Applications, Renewals, and Variations for a Global Healthcare Company in China and Japan

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  • Freyr Provided Strategic Regulatory Partnership Achieving 100% On-Time Submissions and 50% Cost Savings with a Scalable Hybrid Staffing Model for a Japanese Midsize Global Pharma and Biotech Company

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Frequently Asked Questions

What is a PMDA consultation?
A PMDA consultation is an official meeting with Japan’s Regulatory agency to seek guidance on clinical, nonclinical, CMC development plans, or CTD dossier prior to J-NDA.
When should I request a PMDA consultation?
Ideally, before key development milestones—such as prior to initiating pivotal clinical trials or submitting a CTD dossier prior to J-NDA—to ensure Regulatory alignment.
What types of consultations does PMDA offer?
PMDA offers Clinical, Nonclinical, CMC, pre-NDA, GCP/GLP, and Multidisciplinary consultations, among other services.
Is a pre-NDA consultation meeting required?
No, but a pre-NDA consultation is strictly recommended to confirm important review points and how to compensate robustly. For most formal consultations, it is required to clarify the scope, documents, and format of the meeting.
In what language are PMDA consultations conducted?
Meetings are conducted in Japanese, but bilingual (Japanese-English) meetings may be allowed under certain conditions.
How long does it take to schedule a PMDA consultation?
Typically, 2–3 months from application submission to meeting date, depending on the consultation type.
What support can a Regulatory partner provide for PMDA consultations?
They can assist with document preparation, Japanese translation, meeting logistics, strategic question framing, and post-meeting actions, for instance review and fixation of a draft minutes prepared by PMDA.
Is PMDA feedback binding?
PMDA’s advice is non-binding but highly influential and typically followed to avoid delays during review.