Eliquent Japan is a regulatory consulting firm supporting biotech and pharmaceutical companies in entering the Japanese market. From PMDA consultations to regulatory approvals, we provide seamless development support with deep expertise in Japanese regulations and bilingual communication.
Unlike large firms, Eliquent Japan offers the flexibility and specialized knowledge needed to support your development and approval processes in Japan. From PMDA interactions and development strategy planning to dossier preparation, we provide hands-on, practical support tailored to your needs.
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We offer a wide range of regulatory consulting services—
from early-stage evaluations to approval applications and post-marketing lifecycle management for your products.
Below are some of our key services:
01
Our experienced consultants lead the development of communication strategies with PMDA, preparation of a briefing book, responses to queries from PMDA, and support during PMDA consultation to help achieve your goals.
02
With increasing demand for orphan drug designations, our experienced consultants support the development of communication strategies with MHLW, preparation of meeting materials, productive discussions with MHLW, and dossier preparation.
03
We provide comprehensive support including gap analysis between Japanese regulatory requirements and overseas CTDs, preparation of CTDs (in English and Japanese) and eCTD, responses to queries from PMDA, and CTD revisions for Japan NDA.
Meet our industry-leading regulatory consultants
Consultant A
With a background in clinical development and leadership of global projects at a major pharmaceutical company, TS has contributed to the global approval of multiple first-in-class drugs, including in Japan. At Eliquent Japan, TS is highly regarded by our client companies for formulating innovative development strategies for Japan market.
Consultant B
With experience in clinical operations and medical writing at a major pharmaceutical company, HM has led projects in nephrology, rare diseases, and global development programs. At Eliquent, HM has played a key role in simultaneous global approvals and is highly valued by our clients.
Consultant C
As CMC specialist in both small and large molecule drug development, RT has extensive experience from pre-IND to post-approval lifecycle management. RT also supports overseas companies with Japan’s Drug Master File registration, foreign manufacturer accreditation, and GMP inspections, contributing to smooth approvals.
A client aimed to expand indications for a disease with high unmet medical needs. We supported the development of a Japanese regulatory strategy, including adjustments to primary endpoints and a unified dosing regimen. This led to a successful Phase III trial and approval in Japan. With the presence of various contributing factors, and in alignment with the client’s intentions, Japan was ultimately the first in the world to achieve regulatory approval for this project.
While conducting clinical trials overseas, the client company also aimed to initiate clinical trials in Japan. During this process, they faced a regulatory challenge: the possibility that the PMDA might require additional non-clinical study data. Due to differences in the interpretation of non-clinical study guidelines among regulatory authorities, extensive discussions were held with the PMDA. Through ongoing dialogue, the key issues were clarified and negotiations advanced. As a result, the company successfully initiated clinical trials in Japan without the additional non-clinical data.
A client wanted to begin a Phase III trial in Japan without Japanese Phase I data. We conducted a PMDA consultation and demonstrated, based on existing clinical and non-clinical data, that no ethnic differences in safety or efficacy were expected. We secured agreement to proceed with the Phase III trial without Phase I data and clarified the data requirements for the Japan NDA submission.
Join Eliquent Japan
and Contribute to Innovative Drug Development
At Eliquent Japan, you’ll collaborate with biotech companies around the world
and regulatory experts from Europe and the U.S.,
contributing to the development of innovative medicines.
We bring clarity to regulatory complexity at every phase of the product life cycle.
ELIQUENT delivers the answers and solutions life sciences leaders need to gain and maintain market authorization for their products. From concept to commerce and strategy to execution, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges.