Life Sciences
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The advancement of medicine has resulted in the development of research and technology for the treatment of rare diseases and other conditions. Moreover, the development and supply of new treatments and drugs has also progressed. However, due to problems with the reliability and stable supply of pharmaceuticals, the life sciences industry is currently in a position where it must rebuild an environment in which patients can face their illnesses safely and securely. At the same time, life science companies are expected to improve R&D productivity, maintain the quality and stable supply of products and services, and optimize sales and marketing activities, while responding to increasingly stringent legal regulations and price pressure.
QUNIE has extensive capabilities related to Discovery research, CMC research, Clinical development, SCM, manufacturing, Distribution, and CFO/CIO office. We offer a wide range of services to life science companies based on our experience, drawing also on the expertise of experienced professionals from healthcare organizations and regulatory authorities.
■Developing strategy
- – Business strategy
- – M&A strategy
- – Alliance strategy
- – R&D strategy
- – Supply chain strategy
- – Marketing strategy
- – Digital/IT
■Upgrading business management
- – Cost control
- – Forecasting
- – Risk management
- – QC/QA
- – Internal control
■Digital transformation/Business innovation
- – Increased productivity in exploratory research
- – CMC research
- – Clinical development
- – SCM
- – Manufacturing
- – Pharmacovigilance
■New business/Group company start-ups
- – CDMO business
- – Digital therapy/Digital diagnostics business
- – Life sciences business of companies in other industries
- – Japanese business of overseas companies
■System implementation PMO support (for ERP, ServiceNow®, LIMS, MES, EDMS, EQMS, CRM, etc.)
- – Planning concepts
- – Defining requirements
- – Conceptual data model building
- – RFP preparation
- – Vendor/Solution selection
- – Testing
- – Operational structure—including the construction of effectiveness verification and improvement activities
■Compliance support
- – Update and reform of GxP-regulated operations
- – Computerized system validation (GxP validation, AI validation)
■Alliance business support with overseas companies
■Support for clinical research using Real-World Data
