Contract Research Services

Offering Veterinary Pharmaceutical R&D Solutions

Contract Research Services image

Whats we are

Veterinary Pharmaceutical Consultation
  • Clinical trials for animal drugs
  • Quality control studies
  • Specification testing
  • Safety studies

As one of the few veterinary contract research organizations (CRO) in Japan, we are
conducting a diverse range of preclinical and clinical researches every day.
We also offer consulting services for clinical trials, regulatory requirements, and
application and registration for all types of animal health products from pharmaceuticals,
quasi-drugs, and medical devices to feed additives.

Areas of Service

  • Product development
    Product development
  • Pharmaceutical affairs
    Pharmaceutical affairs
  • Regulatory compliance
    Regulatory compliance

Our Capabilities

  • Consultation and support for animal drug application and registration
  • Processes related to feed additive approval and listing
  • Full evaluation of international product registration forms and dossiers
  • Quality assurance auditing
  • Gap analysis
  • GCP studies (cattle, pigs, chickens, dogs, and cats)
  • GLP studies (cattle, pigs, chickens, dogs, cats, and fish)
    • 1) Animal drug safety studies
    • 2) Animal drug residue studies
    • 3) Biological safety studies
  • Quality control studies for veterinary pharmaceuticals
    • 1) Specification setting studies for drug substances
    • 2) Stability studies
    • 3) Safety studies
    • 4) Potency/strength testing
    • 5) Other quality-related studies
  • Post-marketing studies for veterinary pharmaceuticals
    • 1) GPSP-related procedures (preparation of re-evaluation application documents and related support)
    • 2) GPSP studies (efficacy and safety)
  • GMP services for veterinary pharmaceuticals (packaging, labeling, and classified storage)

Certifications & Accreditations

Veterinary Pharmaceuticals and Related Areas
  • Animal drug GLP certification (MAFF)
  • Feed additive GLP certification (MAFF)
  • Animal drug GCP certification (MAFF)
  • Approved academic research organization compliant with the Act on Domestic Animal Infectious Disease Control (MAFF)
  • Authorized to handle live pathogenic organisms of communicable diseases subject to regulatory control (MAFF)
  • Registered animal drug manufacturer and GMP facility (packaging, labeling, and classified storage)
  • Verified to have control measures in place against dissemination of GMOs for Type 2 usage
  • Accredited laboratory animal care facility compliant with animal welfare standards
  • Licensed to receive imported hatching eggs (AQS)
Analytical and Related Areas
  • ISO/IEC 17025:2005
  • Registered clinical laboratory
  • Official measurement certification provider
  • Examination organization of the voluntary food hygiene control certification program
  • JGAP-approved agricultural chemical residue laboratory
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