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)