Our representatives, who have a proven track record in a wide range of areas including anti-cancer drugs and dementia treatment medications, will provide highly specialized services.
We will flexibly respond to customer needs, such as insufficient internal resources for the number of development projects and the desire to hear objective opinions that can assist with applications, and we will support various tasks related to research and development and approval applications.
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basic information
■Consulting - Planning, formulation, and project management from exploratory research to PI initiation - Development planning and PMDA correspondence in the gene therapy field - Planning, formulation, and evaluation of bioequivalence studies - Planning and evaluation of population pharmacokinetic analysis ■Medical Writing - Preparation of clinical trial drug summaries (pharmacology, pharmacokinetics, toxicity) - Preparation of materials for FDA IND (pharmacology, pharmacokinetics, toxicity) - Creation of Japanese CTD based on Global CTD (pharmacology, pharmacokinetics, toxicity), handling inquiries after submission - QC of IB and CTD (comparison of Japanese and English versions, consistency with reports, evaluation of scientific validity)
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Company information
Our company, as a Non-Clinical CRO, provides solutions in the non-clinical field throughout the entire product lifecycle, from research and development stages to commercial stages, including preclinical research, bioanalysis, CMC quality analysis, analysis/measurement of biopharmaceuticals across these areas, consulting, medical writing, and more for pharmaceuticals and medical devices. In close collaboration with our group companies, we fully support our customers' value chain from product development to manufacturing, sales, and marketing across the US, Europe, and Asia. Please feel free to contact us if you have any inquiries.