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"One-Stop-Shop" Service

  • Pre-Clinical Experiment(Total or Partial)
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  • Project management
  • +
  • IND Filling
  • Medicinal Chemistry
  • Process Chemistry
  • Pharmaceutical preparation
  • Pharmaceutical Analysis
  • Pharmacokinetics
  • Pharmacology
  • Toxicology
  • Establish a project plan
  • Work out a whole Sheme
  • Supervise each research
    proposal generation
  • Monitor the progress,
    quality and budget
  • Organize milestone
    review and report
  • Manage sample and
    document
  • Coordinate each research
  • Organize the writing
    of registration materials
  • Participate in filling
    application documentary
  • Arrange claim data for
    special approval
  • submit registration
    materials
  • Communicate with PFDA
    and SFDA
  • Prepare for the On-site
    inspection
  • Participate in evaluation
    defense
Pre-Clinical Development is a system engineering,which involves medicinal chemistry, process chemistry, pharmaceutical preparation, pharmaceutical analysis, pharmacology, pharmacokinetics, toxicology, regis- tration regulation, clinical research and so on. And these research spectra are interrelated and combined into an organic whole.
Pre-Clinical Development is a process of overall design, management, and evaluation,which makes all researches lock into each other, confirm each other, and coordinate with each other. The process not only reflects the overall design of the project,  but also gives consideration to clinical orientation,  project design and registration regulation. And we can make a design of research item and proposal specifically, to ensure the project objectives will be accomplished in an efficient and cost effective manner.
Pre-Clinical Development service is a wide-ranging, whole course of integrated service, based on our extensive experience in pre-clinical development management and well established pre-clinical development platform.
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