BONDS International provides vital support in preparing a wide spectrum of documents including application documents essential for obtaining pharmaceutical approval or clinical trials, and academic papers. These support tasks are in full compliance with the Pharmaceuticals and Medical Devices Act and other guidelines.
We offer medical writing services for new drug approval applications and other pharmaceutical affairs based on our knowledge and past record in the medical translation field acquired over long years. Our medical writers are experts in their own specialized fields, who were responsible for drawing up pharmaceutical applications and related tasks in their previous careers at PMDA, at medical device manufacturers, and at pharmaceutical companies.
Our Medical Writing Service
To prepare and create medical documents, we organize a team of expert staff from task-related backgrounds. We ensure high quality documents in a way similar to a translation job flow, by making meticulous checks at least 4 times in the process or namely; upon receiving incoming materials for translation, on writing the draft including QC, on document completion, and at the final document check.
We also have a system in place to clarify the aim of the task by holding meetings between our expert writers and the client. We then craft a high-quality document by integrating our techniques which are among the best in Japan, to match the client's needs.
- Support in preparing reports relating to clinical studies
- (including clinical study reports (CSR) and PMS adverse reactions case reports)
- Support in preparing documents relating to clinical trials
- (including protocols, clinical study protocols, case report forms (CRF), investigator's brochures (IB) and informed consent forms)
- Support in preparing materials for approval applications
- (CTD, IB, protocols, clinical trial consultations, hearings and PMDA consultations)
- Support in preparing application forms for orphan drug designation
- PMDA consultations, and others
OFFICE: 2-1-15, Nakane, Meguro-ku, Tokyo 152-0031 JAPAN
E-mail: info@bonds-inter.com
TEL: +81 (0)3 5701 5953 (main line)
FAX: +81 (0)3 5701 6599 (main line)
