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About KRB Consulting

Founded by Mr. Lei Zhang and the other partners, KRB Consulting focuses on Regulatory Affairs for drug products, GMP compliance, Quality Management Digitalization, Market Access, and related work for global pharmaceutical companies. As a domestically respected and internationally influential consulting company comprised of industry experts and veteran consultants, KRB Consulting is devoting to accelerating our customers’ drug products approval and to impacting the Industries GxP compliance.

What We Stive For

Our team is professional, dynamic, and far-sighted. We are a friend of time, and are striving to accelerate our customers’ MA approval and GxP Compliance.

660 +

Registration Projects

900 +

GMP Projects

20 +

Global Footprint

510 +

Global Customers

We are pragmatic and risk-aware, and we seek to help companies make compliance much simpler, more effective and international through our closed collaboration and guidance. KRB Consulting help global pharmaceutical companies achieve smooth registration of their brand drugs, generics, API, excipients, and packaging materials in China, and support China domestic customers for their registration and GMP compliance for overseas market. KRB Consulting remain an idea partner because of our capabilities with respect to electronic filing and continues to work assisting with international submission. As needed, KRB Consulting will support customers as their trusted Agent to ensure a prompt and proper milestone achieved.

320 +

Chinese GMP Inspection

110 +

EU/FDA/TGA Inspection

50 +

EU On-site Inspection, 100% Success

50 +

FDA On-site Inspection, 8 Cases Passed without Form 483

15 +

CFDI Overseas Inspections

90 +

Imported/Domestic Drug Registration

10 +

Generic Consistency Evaluation in China

100 +

Imported/Domestic APIs, Excipients and Packaging materials registration

310 +

FDA IND/NDA/ANDA/DMF registration

80 +

DCP/MRP/NP submission (including EDMF/ASMF)

80 +

COS/CEP submission

10 +

ARTG for prescription drug/OTC/complementary medicine

Globalized Consulting Services

A: To help Chinese Pharma and Biopharma to launch their drug products in US FDA, EU (EMA/EDQM/Member Countries), Japan PMDA, Australia TGA, WHO, PIC/S and other countries/regions/Institutes and to pass Official GMP inspections, so to achieve market access in these countries/regions.

B: To help overseas Pharma and Biopharma to launch their drug products with China NMPA and pass China GMP inspection initiated by CFDI, so to achieve China market access.