Medical-scientific Documents in Japanese or English According to Your Strategy and Requirements
We can support medical writing for the purpose of marketing authorization application.
According to your strategy and requirements, we can provide documents which ensure data accuracy and uniformity in compliance with regulatory requirements and International Council for Harmoniszation (ICH) guidelines.
- ICH GCP compliant Clinical Study Reports (CSRs)
- Common Technical Document (CTD)
- Study Protocols
- Investigator’s Brochures
- Patient information including Informed Consent and Patient Brochures
- Pharmacovigilance documents
- Scientific publications (Clinical study, Post-marketing surveillance, Health Economics and Outcomes Research, Review articles)
- Abstracts, Posters, Slides for an International Institution
- Quality control