Drug Development Services Japan

Gain access to the U.S. or European markets through our proven global network of solutions. Discover how we can help meet your goals.

• Nonclinical Development: Our dedicated CFDA GLP certified facility in Shanghai, China features a number of accreditations to fulfill global quality standards (FDA, OECD, etc.). Teaming up with Covance global resources and partners in China, we offer solutions for a full range of safety assessments needed by IND filing and FIH. Specific solutions for small molecules and biologics include: 
  • Lead Optimization
  • Safety Assessment
  • Bioanalysis
  • Drug Metabolism and Pharmacokinetics
  • Chemistry, Manufacturing and Controls
• Clinical Testing - Central Laboratory Services: Our dedicated facility in Kawagoe City provides a variety of solutions including:
  • Core Laboratory Services: Chemistry, Hematology, Urinalysis and Hemoglobin A1C, Specimen Management and Short-Term Storage
  • Custom Japanese investigator kit 
• Other Central Laboratory Services are provided through our neighboring Singapore facility including:
  • Core Laboratory Testing services:
    • Genomics Services
    • Special Chemistry
    • Immunochemistry
    • Hematology
    • Flow Cytometry
    • Specimen Management and Biorepository
    • Safety Testing
  • Anatomic Pathology
  • Biomarker Services
  • Scientific Consultation
  • Data Management
  • Project Management
  • Investigator Ste Support
  • Global Logistics

• Clinical Trial Support: Improve operational efficiencies and accelerate your timeline with our streamlined start-up process.   
  • Early Clinical/Phase IIa
    • Clinical Pharmacology
    • Early Patient Studies
    • Clinical Trial Project Management and Monitoring
    • Complete PoC^®
  • Phase IIb/III
    • Xcellerate^® Clinical Trial Optimization^®
    • Clinical Trial Management
    • Xcellerate^® Monitoring
    • Drug Safety
    • Functional Service Provider
  • Life Cycle Management
  • Clinical Data Analysis and Reporting
  • Regulatory

We understand the level of service and attention to detail expected for all interactions. As your partner, we are equipped to satisfy your needs and provide insights to move your project forward.

• Diverse expertise: Benefit from the vast breadth and depth of knowledge from our scientific experts and managers to help meet your challenges. Our experts are fluent in both Japanese and English to help facilitate clear and streamlined communication.
• Regulatory support: Get experienced consulting with your product development plan and regulatory submissions from our regulatory personnel who have years of product development experience and proactively stay abreast of the latest regulatory changes. Register your compound in the U.S., European and Rest-of-World with the support of our skilled regulatory staff who have extensive experience interacting with PMDA, FDA, EMA and other Health Authorities globally. 

The Japanese healthcare market is often characterized by its aging population and traditionally high use of medicines. Japan has number of other attributes to consider in the industry:

• A strong presence: When compared country by country, the Japanese pharmaceutical sector is the second largest in the world with the U.S. as first and Germany as third.
• Sophisticated knowledge: The Japanese clinical drug development market is considered very mature as compared to other emerging Asian Pacific countries.
• Opportunities for generics: The generic drug sector is increasingly attractive to foreign manufacturers given that government initiatives are aimed at reducing healthcare spending and meeting the needs of a rapidly aging demographic. 

At Covance, we understand all of these factors that make Japan an attractive yet challenging market for partnerships, both locally and globally. We’re ready to work with you and explore what’s possible.