CTD writing

Preparation/review of development/regulatory documents and approval application materials

Our reviewers and pharmaceutical affairs consultants, who have decades of experience in their fields (research, development and application) with major domestic and foreign capital pharmaceutical companies, provide bespoke high-quality products and solutions, in collaboration with our expert translators, CTD writers, medical writers, and QC personnel.

For clients who require consulting, we can assess your existing data and advise the additional (study) data required, based on our extensive Japan market experience.

Clinical Trial Notification, Change of Clinical Trial Notification

clinical data attachments/addenda required for the notification; documents supporting the sponsoring of clinical trials as considered scientifically justifiable, and ADR reports


Approval application dossiers for new drug/ generic drug, CTD/eCTD, PMDA consultation materials, Documents for public knowledge-based applications

Designation of Orphan Drugs and Medical Devices

Documents of Clinical / CMC and Preclinical

Standard Operating Procedure (SOP), Investigator’s Brochure, Protocol, Informed Consent Form, Case Report Form, Clinical Study Report, Reports of other studies (e.g. CMC, pharmacological/toxicity,and pharmacokinetic studies)

Applications for INN/JAN, MF and compliance inspection

PMS activities

CIOMS, Package Insert, PSUR, Line listing, Reexamination applications, etc.

Interview forms, academic papers

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