KRB金瑞博

About KRB金瑞博

Beijing King RaBroad (KRB) Consulting Inc.
KRB Consulting is a Chinese consultancy engaged in regulatory compliance consultation for the pharma industry. We focus on providing regulatory affairs services, GMP compliance, QMS digitization, and related services for the pharma industry around the globe. Our goal is to help pharma companies pass the registration and GMP inspections in the target ...

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  • CN
  • 2022
    On CPHI since
  • 25 - 49
    Employees
Company types
Consultancy
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Products from KRB金瑞博 (3)

  • GMP Consultation

    Product GMP Consultation

    Onsite/offsite gap analysis of the quality management system for pharmaceutical companies against Chinese GMP, cGMP, Eudralex GMP, PIC/S GMP, and WHO GMP guidelines; Provide recommendations on gap-bridging; Carry out mock up audits and assist in correction of findings; Provide onsite technical support and ...
  • Regulatory affairs services

    Product Regulatory affairs services

    I. SERVICES 1. Submission of ANDA, NDA and IND applications with NMPA; (including the whole service from GAP analysis, compiling, submission, sample testing, CDE review procedure tracking and supplemental info preparation); 2. GAP analysis and application strategies setup before the submission to NMPA; 3. ...
  • Translation services

    Product Translation services

    We have professional translators that can provide: - English & Chinese interpretation services during international GMP audits; - English & Chinese interpretation services during communication with NMPA and other authorities; - English & Chinese translation of audit reports / CAPA reports; - En...