Supply Chain Management and CMC consulting focused on development phase

Overview

We focus on drug development stage and manufacturing strategies to the pharmaceutical industry, concentrating on providing services to emerging and specialty pharma companies. Our CMC consulting service supports transition of our client’s projects from Med-chem to Process-chemistry stage. We expertise with chemical, fermentation, drug product and analytical development, supply chain strategy, manufacturing operations, quality control, quality assurance and regulatory affairs.

Drug development and research business by using MRI and PET

Overview

We are Japan’s first CRO utilizing experimental MRI and PET contributing to saving time, reduction in cost and the number of laboratory animals by making good use of our experience and expertise in pharmacological imaging as below, and also conducts MRI-safety evaluation.

Consulting Service, Safety Management Service, Post-Marketing Pharmaceutical Service

Overview

Support resolving company’s problems with broad services.
1. Consulting Service
・Advise and interview support for responding inquiry matters to authorities
・Support obtaining and renewing the authorization of manufacturing and distribution
2. Safety Management Service
・Accept whole medicine and medical device’s safety management operation
3. Post-Marketing Pharmaceutical Service
・Construct package insert and related documents
・CMC pharmaceutical operation

Designing and creating instructions for medical devices

Overview

Electrosuisse Japan Started the business at Kobe in January 2007.
Electrosuisse Japan conducts support services for instruction manuals for medical devices, etc. against the background of its extensive track record which comprise designing, producing and translating, as well as consulting, etc. for risk analysis which is based upon usage environments and user perspectives, and performing usability tests, and complying with ISO standards and standards, etc.
In addition, Electrosuisse Japan is carrying out gap analysis and adaptation measures technical support to incorporate the viewpoint of risk and benefit communication, which USFDA is focusing on in recent years, into documents for medical equipments and documents for medical facilities.

Overview

We support effective development of valuable drug candidates and utilization of drug development technologies in pharmaceutical companies, startup companies and academia. Our company’s name, Gemseki, was created by combining ”gemstone” and “genseki (gemstone in Japanese)” with hope of identifying these hidden drug candidates and turning them into valuable new drugs. We support the search for license partners by transmitting information utilizing an open platform on the Web and making introductions to individual companies. (We are a subsidiary of Shin Nippon Biomedical Laboratories, Ltd., which is a member of the KOBE Biomedical Innovation Cluster.)

Conducting a consulting business in the field of medicine

Regulatory consultation and clinical development service for medical device, regenerative medicine/pharmaceutical product

Overview

In April 2018, healthcare consulting firm IMS Health together with the CRO / CSO firm Quintiles Japan, combined to form the IQVIA Japan Group, with a corporate name change and rebrand. IQVIA a world leading company, with over 55,000 employees in more than 100 countries, offering information, innovative technology, and clinical trial services, utilizing data and science to the help the life science industry bring better solutions to patients.

R&D assistance and evaluation of medical equipment

Overview

In a wide range of fields from the nano region to large-scale structures, we provide high reliability analysis and evaluation technologies using state-of-the-art analysis and testing equipment. Our technical staff of 500 experts possesses a wealth of experience, and is ready to assist clients in solving technical problems in all aspects of “monodzukuri” : such as stabilization of product quality, added functions, and reduction of production costs.