I propose new initiatives and solutions to challenges in the IT environment and business processes of pharmaceutical companies, particularly related to GXP regulatory requirements.
**Overview of Consulting Services for Pharmaceuticals and Medical Products** ● Business Consulting for Pharmaceutical Companies and Research Institutions We conduct investigations and analyses of business processes aimed at compliance with regulatory requirements, improving operational productivity, and maintaining and enhancing quality. We propose measures to address gaps in organization, structure and roles, business flows, and quality management, and support the stabilization of new processes after improvements. ● System Consulting for Pharmaceutical Companies and Research Institutions (Regarding System Evaluation and Implementation) We investigate and analyze the computer systems used in operations related to regulatory requirements to ensure the integrity, reliability, and trustworthiness of the systems, as well as the authenticity, readability, and maintainability of the electronic data handled. We provide proposals for measures to address gaps and risks that should be implemented by pharmaceutical companies and research institutions. ● Consulting for System Suppliers (Regarding Requirements for Service Suppliers to Pharmaceuticals and Medical Companies) We conduct investigations and provide guidance for improving the quality of systems required by GXP and for the preservation of processes and essential documents and records related to supplier investigations. Additionally, we participate in supplier investigations from the supplier's perspective, addressing questions and comments.
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basic information
The personnel assigned by our company will vary depending on the scope of the target business (GxP) and the scale of the system. Please feel free to contact us first.
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Applications/Examples of results
This service has a track record of over 20 companies in pharmaceutical companies, medical institutions, and other research organizations. Additionally, we enter into separate consulting contracts with companies and institutions to provide ongoing support.
Detailed information
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In the pharmaceutical industry, regarding the phases of drug discovery, research and development, and post-marketing safety management, staff with knowledge of regulatory requirements and business processes will investigate and analyze the current situation surrounding the IT environment and business processes related to GxP compliance, as well as the introduction of new business processes (particularly those related to GxP regulatory requirements). Based on the investigation results, they will clarify issues and risk countermeasures and formulate improvement proposals.
Company information
Our company is committed to promoting appropriate IT investments and utilization in businesses by investigating the current situation, including operations, environment, and strategy, and proposing and providing systems that align with the original business, scale, and regulations while suppressing excessive investment in IT. In particular, we focus on the development, sales, and support of software related to the entire process of research and development of pharmaceuticals for the pharmaceutical industry, as well as supporting pharmaceutical development operations and providing consulting for IT implementation, all while offering comprehensive support for systems that comply with the regulations (ministerial ordinances and guidelines) of the Ministry of Health, Labour and Welfare. Please feel free to contact us if you have any inquiries.
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