We have compiled a list of IT and DX systems and services to improve efficiency for pharmaceutical and medical device companies.
Supporting research activities from candidate substance discovery to commercialization for new drugs, regenerative medicine, and in vitro diagnostic drugs
A system for properly managing clinical trials of new drugs and regenerative medicine products
Supporting approval applications, inquiries, and regulatory compliance for pharmaceuticals, regenerative medicine products, and OTC products
Ensuring safety by collecting, analyzing, and reporting information on side effects and adverse events
Quality assurance, testing, and document management based on standards such as GMP/GCTP/ISO13485
Achieve high-quality manufacturing through production planning, process monitoring, record management, etc.
Supporting proper storage, transportation, and supply management of pharmaceuticals, regenerative medicine, and OTC products
Support areas including MR activity support, DTC marketing, and education and information provision
Medical device design, simulation, material development, and life cycle management support
Manages performance testing and clinical evaluation of medical devices and in vitro diagnostics
Compliance with MDR/IVDR, UDI numbering, and regulatory affairs including in vitro diagnostic drug system compliance
Support for complaint and defect management, post-market surveillance, etc.
Integrated management of processes such as manufacturing, assembly, engraving, and traceability management
General maintenance activities such as inspection, repair, replacement, and remote monitoring
Manage shipping, inventory, sales channels, traceability, etc.
Operation guidance, user education, FAQ and support information provision support