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Service Type*

Quality CRO Platform

Human genetic resources management consulting

 

Consultation Process

  • Preliminary Assessment
     
  • Ethics Review Preparation
    Documentation Compilation
    Key Review Criteria
     
  • Application Dossier Preparation
    System Documentation,Application Materials
     
  • System filling/System Submission
    Application Filing
    Follow-up Feedback
     
  • Pre-Submission Rehearsal
    Defense Preparation & Techniques
     
  • Approval & Publication
     
Service Scope
  • On-Site Audit: Organizational structure and workflow optimization; Non-compliance rectification
  • Regulatory Training & Compliance Planning
  • Ethics Review Support: Documentation preparation and system implementation
  • Pre-Submission Review & Personnel Capacity Building
  • Defense Preparation & Technical Review Rehearsal
  • Comprehensive  personnel capacity enhancement



7 Service Categories:4 Administrative Permits + 1 Filing + 1 Report + 1 Application
  • 4 Administrative license: collection, preservation, international scientific research cooperation, material export
  • 1 Registration: International Cooperation Registration
  • 1 Report: Provided to the outside world and open to use
  • 1 declaration: major human legacy resources
Service process
  • Research project situation:The actual situation of the project will be investigated, including but not limited to the existing materials, management document system, customer site and facilities of the project, and the survey will be summarized and fed back to the customer.
  • Collection/Preservation Entity Qualifications:
    1.Legal Entity Status: The entity must be a legally registered organization.
    2.Lawful & Defined Purpose:Activities must have clear, legitimate scientific or medical purposes.
    3.Scientifically Sound Plan:The operational plan must pass scientific and ethical review.
    4.Legal Source of HGR:Ensure HGR sources comply with national regulations.
    5.Ethics Approval: All activities require approval from an independent ethics committee.
    6.Dedicated HGR Management Department: Establish a dedicated department and management protocols.
    7.Compliant Facilities & Personnel: Facilities, equipment, and staff must meet national technical standards.
  • Guidance and sorting materials:The writing template for the required materials, the system operation guidance of the government service platform of the Ministry of Science and Technology, etc. will be provided based on the survey situation, so as to sort out and write materials.
  • Evaluation materials to finalization:The materials will be written according to the customer's situation, evaluate their integrity, put forward modification opinions, discuss and communicate with the customer until the materials are finalized.
  • Formal submission of materials:After the materials are finalized, guide customers to submit the submission system. According to the feedback from the Ministry of Science and Technology, assist customers in making material modifications.
  • On-site investigation (if required):During the expert on-site investigation stage, relevant staff will be arranged to accompany the partner to review.