Lei Zhang-KRB CONSULTING | Beijing KRB

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Name: Lei Zhang

Position: Founder /General Manager

Lei Zhang

Founder Partner/General Manager

Background:

• GMP expert/WHO LPA project consultant

• Engaged in domestic and international GMP compliance projects since 2013. As the principle responsible person, led and participate in 110+ GMP certification projects including NMPA/US FDA/EU/WHO/TGA GMP. Particularly good at international GMP compliance for sterile pharmaceuticals, assessment and correction of data integrity (DI), compliance of premises/facilities/ equipment, handling of complex non-compliance issues, build-up of quality culture, M&A/investment consulting.

Prior to founding KRB Consulting:

Canny Consulting - General Manager (from 2013)

Qilu Pharma - production and quality management of sterile pharmaceuticals/oral chemicals

Good at:

• International GMP inspection support	• GMP compliance for sterile FDF/API
• GMP compliance for biologic drug	• Regulatory compliance of data integrity
• Build-up of GMP concept and quality culture
• Analysis and resolving of complex deviations / problems
• Due diligence GMP audits for acquisition of product and entities