KRB金瑞博
About KRB金瑞博
Categories
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CN
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2022On CPHI since
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25 - 49Employees
Company types
Products from KRB金瑞博 (3)
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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 ... -
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. ... -
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...
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