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Medical Writing

Medical Writing Services
Using our knowledge and experience in medical translation, Honyaku Center has developed medical writing business for new drug applications.
Since our founding in 1986, medical translation has been central to Honyaku Center's business. With the support of our clients, we have become the leading translation specialists.
A major part of our work involves translations for new drug application (NDA) materials, covering an important step in new drug applications in Japan and overseas.
As part of this process, we also provide medical writing for clinical trials for new drugs developed in Japan, and we translate overseas data for imported and exported drugs. Using the knowledge and experience we have acquired, we provide the highest quality medical writing.
Our medical writers are all experienced with pharmaceutical companies with specialties in pharmaceutical affairs and clinical trials.

Details of Medical Writing
Documents and materials for new drug application
- CTD (quality, nonclinical, clinical)
- Investigator's brochures
- Clinical Study Reports
- Submission Articles
- Clinical Trial Plan
- Quality Control (including logic check)
- Diagram creation from original documents
* Separate fees are charged for translation, data entry, photocopying and printing.

Order Received Preliminary discussion with coordinator, writer and client.
Medical Writing Primary work by medical writer.
Quality Assessment Primary check by quality assessment staff.

Editing

Editing by operator.
Revision by client
Rewrite Additional revisions by medical writer, quality assessment staff, and operator.
Final Delivery

Medical writing requires access to vital internal documents. To ensure your security, we sign a non-disclosure agreement beforehand, store documents securely, and also bind the medical writer to a non-disclosure agreement.
In addition to the relevant documents, we require a template or a similar report as a reference in order to maintain consistency with past reports.
Please take this into consideration and we thank you in advance.
If you have any questions or inquiries, please do not hesitate to contact us for further information.
Contact : Mr. Tsunoda
TEL:+81-3-6403-9952 FAX:+81-3-6403-9962
medwr@honyakuctr.co.jp

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