Expertise in Expedited Drug Development Approvals

Whether clients need Regulatory Affairs support, CMC Consulting, or regulatory submissions and correspondence, CMIC has the strong Regulatory Affairs (RA) Department and consultants needed to support product development. Our regulatory consultants have expertise in oncology, orphan drugs, medical devices, and many therapeutic areas. We offer expedited, fast track drug development and approvals, while following ICH guidelines. We also provide Orphan Drug designation support, perform Japan Accepted Name (JAN) Applications, interview clinical and non-clinical Key Opinion Leaders (KOLs), and support clinical trial notification (CTN), New Drug Applications (NDA), and PMDA consultations. Our Regulatory consulting services are available in China, Korea, Taiwan, Hong Kong, Singapore, Malaysia, Thailand, Vietnam, and the Philippines, with the ability to support US and European biopharmaceutical customers.

Our Edge in Regulatory Affairs Consulting

Strong Regulatory Authority Knowledge

  • Experience with a wide range of regulatory matters and various authorities such as PMDA and MHLW, including preparation of supporting documents, application dossiers and responses to the authorities’ queries.
  • Flexible support by consultants from various groups (e.g. development of combination products by consultants from the Drug Group and the Medical Device Group).
  • Provide up-to-date information through a strong network with external professionals.

Accumulated Knowledge and Expertise

  • Japans’ largest regulatory consulting group, with over 20 years of experience supporting strategic planning and detailed clinical trial protocol design.
  • Providing high-quality documentation in collaboration with Medical Writers who work in the same division of CMIC.

Extensive Experience

Each of our consultants employ professional expertise in an array of areas, offering high-quality consulting services

Services

  • Consulting on new drug application and CTD
  • Generic products consulting
  • GLP, GMP, GCP, GVP, GQP, and GPSP consulting
  • Evaluation of CMC data, nonclinical test data and clinical trial data for conducting clinical trials and/or NDA filing in Japan
  • Orphan Drug Designations
  • Support for PMDA consultations
  • Support for Clinical Trial Notification (CTN)
  • Interviews with KOLs (clinical and nonclinical)
  • Other services

CMC Consulting

Regulatory Submissions and Correspondence

Medical Writing

Medical Device Consulting

Drug Development Consulting