KunTuo

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Regulatory Affairs

Kun Tuo is fully committed to providing you with regulatory and associated consulting services for pharmaceutical and Medical Device & Diagnostic (MDD) products. Our goal is long-term cooperation with you.

Our strengths

  • Extensive experience
    With several years’ experience in the registration of domestic and imported products and an in-depth understanding of China regulatory environment, laws and technical requirements, we are able to identify current trends in policies and regulations at an early stage. We are familiar with the product registration review and approval process and maintain firm, effective communications with the regulatory authorities. We have expert knowledge of ICH technical requirements and can convert differing foreign and domestic registration application materials from one format to another.

    We are recognized for our excellence in establishing and adjusting product registration strategy in China. This is accomplished with an in-depth understanding of China’s changing regulatory environment, laws and technical requirements for drugs and Medical Device & Diagnostic (MDD) products – and through effective communication between our Chinese team, regulatory authorities and overseas customers.

  • Support from Quintiles
    Quintiles shares the resources and experience of its regulatory affairs team when developing practical registration strategies and advice for our customers.

Our regulatory affairs services

  • Product due diligence and regulatory consultation
  • Regulatory feasibility analysis and evaluation
  • Registration strategies development
  • Preparation and submission of registration submission dossiers
  • Specification verification and product test
  • Follow up with registration schedule and project management
  • OTC switch application
  • IP import license application
  • Regulatory filing of clinical trial
  • Medical Device & Diagnostic (MDD)
    • Initial registration, re-registration, change of registration
    • Product technical requirement/standard preparation
    • Regulatory and R&D strategy consulting
    • Development of Clinical Evaluation Report (CSR)
Regulatory Affairs