Since the announcements made by the Japan-US-Europe International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in protocols such as the “Guidelines on Structure and Content of Clinical Study Report” in 1996 and “How to Prepare Materials to be Attached to Application for Approval in Applying for Approval of Production and Import of New Medical Drugs (M4)” in 2001, pharmaceutical companies have been required to prepare their documents in accordance with these global standards when applying for manufacturing approval of pharmaceutical products and medical devices. High-quality scientific documents that are logical and consistent within a limited time frame. These documents include clinical study reports and Common Technical Documents (CTDs), investigators’ brochures, clinical study protocols, materials on clinical trials used for consultations with the Pharmaceuticals and Medical Devices Agency (PMDA), and written replies to matters of inquiry.
I established TMK medical writing service in 2006 after eight years in clinical development work at a Japanese pharmaceutical company and an additional ten years working as a medical writer for a foreign-affiliated CRO in Japan. On a contract-basis, I can prepare all the documents necessary from designing development plans for medical products and devices to the acquirement of the application for approval as well as other medical writing, such as the preparation of post-marketing surveillance and safety evaluations and re-examination applications.
I work as a freelancer with foreign-affiliated pharmaceutical companies and other healthcare-related companies to prepare various regulatory and clinical study documents, as well as CTDs in both Japanese and English across a wide range of therapeutic areas. As a professional medical writer, I am dedicated to providing a variety of high-quality medical writing services that will contribute to the success of your development strategies and meet your compliance requirements.
I would be much obliged to discuss our potential collaboration on your pharmaceutical projects and medical writing needs. Please feel free to contact me at my firm if I can ever be of service to you.
TMK medical writing service (freelance medical writer) 2006-
Engaged in medial writing work in a foreign-affiliated CRO 1996-2006
Involved in clinical development work in a Japanese pharmaceutical company 1988-1996