• HOME
  • Services
  • Non-clinical consultation/Clinical consultation

Non-clinical consultation

  • Non-clinical due diligence assessment
  • Non-clinical data assessment
  • Non-clinical study plan advisory
  • Advisory on Non-clinical study strategy for NDA based on guidelines
  • CLO selection and GLP audit advisory
  • Non-clinical study protocol support
  • Non-clinical study report support
  • Support for regulatory consultation with PMDA
  • Preparation of NDA submission and CTD
  • Support with Compliance Inspection of Non-clinical documents
  • Assistance for PMDA pre-assessment consultation
  • Support with PMDA communication (response to questions) after NDA submission
  • Assistance for CTD revision for the drug committee
  • Review report and CTD masking assessment
  • Advisory on Non-clinical development strategy plan for life cycle management

Clinical consultation

  • Clinical due diligence assessment
  • Clinical data assessment
  • Clinical study plan advisory
  • Advisory on clinical study strategy for NDA,including PMDA consultation
  • PMDA regulatory consultation support
  • Clinical study protocols assistance
  • Clinical study management and implementation assistance
  • Clinical study data management advice
  • CRO selection and GLP audit advisory
  • Clinical study report assistance
  • Clinical trial notification assistance
  • PMDA pre-assessment consultation assistance
  • Preparation of, and advice on, NDA submission and CTD
  • Support with clinical compliance inspection of documents and GCP
  • Support with PMDA communication (response to questions) after NDA submission
  • Assistance for revision of CTD for the Drug Committee
  • Review report and CTD masking support
  • Advisory on clinical development strategy for product life cycle management
Page Top