Service
Description
Medical writing/Academic writing/ Pharma translation
Medical writing: Pharmaceutical documents and regulatory documents for drug approvals
Publication support: Original articles, research paper
Translation: Pharmaceutical documents (for clinical trials and regulatory documents for drug approvals)
Languages
Japanese, English
Areas of expertise
Biopharma (preclinical research), Oncology, Central Nervous System
Experience
Regulatory Affairs
Clinical trials & drug approvals
Protocol, Clinical Study Report, Investigator's Brochure, Chemistry Manufacturing and Control (CMC), Informed Consent Form, Case Report, Standard Operating Procedures, Inquiry and response between sponsors and Japanese authority, Common Technical Document (Quality overall summary: module 2.3.P, 2.3.S/Quality: 3.2.P/Clinical overview: 2.5.3, 2.5.4, 2.5.5/Clinical summary: 2.7.3, 2.7.4, 2.7.6)
Medical Affairs/Marketing
Minutes, Sales promotion materials, Power point slides, Interviews
Academic Institution
Manuscripts, Academic conference, Symposium, Annual meeting
Others
Content creation for e-learning courses
Subtitle translation
Indication
Bipolar disorder, Schizophrenia, Epilepsy, Insomnia, Ovarian cancer, Breast cancer, Endometrial cancer, Cervical cancer, Rheumatoid arthritis, Chronic myeloid leukemia, Acute lymphoblastic leukemia, Malignant lymphoma, Cutaneous T-cell lymphoma, High-frequency microsatellite instability (MSI-High) cancer, Non-small-cell lung cancer, Esophagus squamous cell cancer, Urothelial cancer, Chronic kidney disease, Thromboembolismt, Trans-suppression of misfolding in an amyloid disease, Essential thrombocytosis, Hypophosphatasia, Hepatitis C, Glaucoma, Age-related macular degeneration, Neuromyelitis optica, Psoriasis
Biomedical/Biopharma
Cancer genomic medicine, Immunotherapy, Cell and gene therapy
Medical Device
Plastic and reconstructive surgery (prosthetics, electric prosthetics), Virtual reality (VR), mixed reality (MR)