01
Development Strategy
We develop strategies for development and regulatory approval in Japan based on research into competing products under development.
Regulatory Consulting
Clinical Development in Japan,from Concept to Marketing Approval Application
Accerise, Inc. provides a broad range of support for products including pharmaceuticals, medical devices and regenerative medical products.
Our services cover assessments of Japan's market and development landscape, regulatory strategy, PMDA consultations, clinical trial notifications (CTNs) and marketing approval applications.
OUR STRENGTHS
The Right Approach and Flexibilityfor Your Project
Accerise, Inc. responds quickly and flexibly to your project's needs and challenges.
From regulatory strategy and PMDA consultations to clinical trial notifications, CTD/STED preparation and responses to regulatory queries, we tailor the scope of support to your requirements.
SERVICES
We provide regulatory consulting tailored to each stage of your project, from assessing entry into the Japanese market and defining regulatory and development strategies to preparing marketing approval applications.
02
Development & Study Planning
We help plan development programs and studies around Japan's medical needs and regulatory requirements, with future marketing approval applications in mind.
03
PMDA Consultation & Clinical Trial Notification
We support the preparation of briefing documents for PMDA consultations, responses to regulatory queries, clinical trial notification submissions, and jRCT registration to support the smooth initiation of clinical trials.
04
Marketing Approval Application Support
We assist with preparation and review of application dossiers, eCTD submissions, and clinical study data, including CDISC-compliant datasets, as well as responses to queries during PMDA review.
05
Orphan Drug Designation & Related Regulatory Support
We support applications for orphan designation and related regulatory programs for pharmaceuticals and medical devices.
SELECTED EXPERIENCE
Regulatory Strategy & Development Planning for Japan
Japanese Market & Development Landscape Assessment
PMDA Consultations:Briefing Document Preparation & Responses to Regulatory Queries
Clinical Trial Notification (CTN) Support
Orphan Drug Designation (ODD) Support
Marketing Approval Applications & CTD Preparation
HOW WE WORK
01
Initial Inquiry & Needs Assessment
We review your product information, development status and the support you are seeking.
02
Proposal & Quotation
We propose services and an approach tailored to your requirements, together with a quotation.
03
Agreement & Project Kickoff
After you approve our proposal and the agreement is signed, we begin work.
04
Work Completed
We review progress and deliverables to ensure that agreed project objectives are met.
CONTACT US
Talk to Us About Your Regulatory Needs
Whether you are exploring entry into the Japanese market, preparing for PMDA consultations, initiating clinical trials or planning a marketing approval application, we can discuss the support you need at your current stage.
Inquiries are handled through the contact form on our corporate website.
Contact us here