2025.09.01
[Important Notice] Notification of Sales and Service Termination for "uniStyle"
Service
Business support and consulting services
Visit support for eCTD publishing
We offer on-site visit support to customers, tailored to their specific needs, to provide eCTD publishing services. This service is available for situations where the provision of application data is not possible due to company policies or when there is a need to work together as a collaborative team.
(For inquiries, please contact us here)
Consulting
We provide technical support and consulting services based on our track record and expertise to customers who are facing challenges in the eCTD application environment and publishing process. We conduct risk analysis from various perspectives and compile the necessary actions, providing comprehensive support in setting up the environment.
For customers facing challenges in the eCTD application environment and publishing process, we offer support and risk analysis from various perspectives, including providing templates and writing guidelines for application documents, conducting quality control of Word documents, verifying and preparing PDFs for submission, eCTD compilation (folder structure, XML instances, external link creation), and electronic submissions. We also propose eCTD environment construction plans and eCTD creation solutions that comply with eCTD v4.0.
(For inquiries, please contact us here)
Drug substance (DMF) application
We started supporting the eCTD application of Drug Master Files (DMFs) in August 2014 and have provided support to a total of 35 drug substance (also known as active pharmaceutical ingredient, API) companies and others. In the fiscal year 2023, we have supported a total of 122 applications and management of DMFs, Active Substance Master Files (ASMFs), and Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs).
Since May 5, 2018, the submission of DMFs in eCTD format has become mandatory for approval applications of active pharmaceutical ingredients and intermediates to the U.S. Food and Drug Administration (FDA). The eCTD format is also applied to annual reports, amendments, and Letters of Authorization (LOAs) for approved DMFs.
We support various activities, including DMF applications for the FDA, registration of ASMFs for the European Medicines Agency (EMA), CEPs, and the creation, registration, application, maintenance, and management of API master files for regulatory authorities in various countries such as Health Canada, Swissmedic, and the Therapeutic Goods Administration (TGA) of Australia.
(For inquiries, please contact us here)
New drug applcation (NDA)
Our predecessor, Cellec Co., Ltd., supported the first domestic submission of a New Drug Application (NDA) in eCTD format in 2005. Since then, our company has expanded its business to 30 companies and provided support for a total of 31 NDA applications, including lifecycle managements, in the fiscal year 2023.
We offer outsourcing services for transforming a Word document to eCTD for New Drug Applications (NDAs) to the Ministry of Health, Labour and Welfare, the Pharmaceuticals and Medical Devices Agency (PMDA), the U.S. Food and Drug Administration (FDA), and other regulatory authorities. Our services are provided to domestic major pharmaceutical companies, overseas mega-pharmas, and Contract Research Organizations (CROs).
Currently, electronic submissions are in a transition period from eCTD v3.2.2 to eCTD v4.0. Electronic submissions using eCTD v4.0 started in Japan on April 1, 2022, and are scheduled to begin in the United States, Australia, and Brazil in 2023, and in the EU, Switzerland, and Canada in 2024.
Our Operation Department, consisting of experts with extensive work experience and knowledge, handles electronic QC and validation of Word documents, verification and preparation of submission-ready PDFs, creation and verification of XML instances and external links, and the creation of high-quality application packages (eCTD v3.2.2 and eCTD v4.0 for Japan and the United States) that meet eCTD requirements. We also provide support for lifecycle management and variations.
(For inquiries, please contact us here)
