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Clinical Development Division
Development an Medical Affairs

Discovery Research Department evaluates candidate compounds for development, screens pharmacological actions, elucidates their mechanism of actions, and searches for new seeds. It also carries out synthetic researches for optimization of drug formulations as well as for the study of metabolite and degradation products.
Pharmaceutical Research Department mainly conducts CMC and preclinical studies in preparation for PMDA submissions, aiming to bring the candidate pharmaceutical products quickly to the market. It carries out physicochemical studies, stability testing, and establishes test procedures and acceptance criteria for CMC development. Concurrently, it conducts pharmacokinetics and safety studies for preclinical development. In addition, it evaluates efficacy of various disinfectants using microorganisms to help improve the products for infection control.
Department of Project Management and Research Planning serves as a liaison between related departments and divisions. Their jobs are management of ongoing R&D projects, information search around the R&D themes and other general management.
These three departments establishes and maintains infrastructure that conforms to standards such as GLP and quality. Furthermore, animal welfare is always taken into consideration when conducting animal studies. Each department strives for more effective and safer pharmaceutical drug development to contribute to maintaining healthy lives of people.
Clinical Development Department conducts clinical trials of the new drug candidates whose efficacy and safety were confirmed in non-clinical studies, under Good Clinical Practice(GCP)- from phase I to phase III studies - to confirm their efficacy and safety in human. Then, it obtains manufacturing and marketing approval of new drugs. After drugs are marketed, Pharmacovigilance and Post-marketing Surveillance Department collects information including efficacy, safety and quality in accordance with Good Vigilance Practice(GVP), focusing on adverse effects which were not detected during clinical trials. Furthermore, it conducts post-marketing surveillance and post-marketing clinical trials following Good Post-marketing Study Practice(GPSP)to provide information for proper use to medical professionals and patients. Through these post-marketing follow-ups, we foster pharmaceutical drugs into more effective and safer ones.
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