QUALITY CONTROL SOLUTIONS LTD(QCS Pharmaceutical R&D Center)—Global Leader in Pharmaceutical Reference Materials Research & Development and Innovation Platform

A globally integrated, internationalized innovation platform dedicated to the research, development, and commercialization of pharmaceutical reference materials and impurities. QCS is committed to delivering high-purity, fully traceable, and rigorously standardized reference substances—as well as tailored small-molecule solutions—to the global pharmaceutical industry.  

The company operates under the dual foundational accreditations of ISO 17034 (for certified reference material producers) and ISO 9001 (for quality management systems), and has established a comprehensive, end-to-end technical ecosystem spanning research, manufacturing, and analytical testing. QCS serves more than 5,000 pharmaceutical enterprises across over 100 countries, with its portfolio encompassing 100,000+ reference materials for active pharmaceutical ingredients (APIs), metabolites, degradation products, and related impurities. The QCS brand achieves annual global sales exceeding RMB 100 million, employs a team of over 170 highly skilled professionals, and maintains a robust presence in all major pharmaceutical markets worldwide.  

Core Business and Technical Capabilities  

1. Reference Materials and Impurity Research  

- Separation, Preparation, and Structural Confirmation: Expertise in chemical synthesis and natural product isolation to ensure accurate structural identification.

- Reference Material Development: Provision of value assignment, stability studies, and characterization services in compliance with ICH, USP, EP, and other international standards.

- Analytical Method Development and Validation: Support for the development and regulatory validation of analytical methods including HPLC, NMR, and MS.

2. Custom Synthesis of Specialized Small Molecules

-High-Purity Compound Synthesis: Capable of synthesizing complex molecular structures such as pharmaceutical intermediates and APIs.

-Customized Complex Molecules: End-to-end support from molecular design to commercial-scale production.

3. Full Lifecycle Management  

- Comprehensive stewardship across the entire lifecycle of reference materials—from R&D, production, and testing to storage and application—ensuring data integrity and traceability.

Research and Development Platform and Facilities  

1. Experimental Facilities  

- Over 6,000 m² of specialized laboratory space equipped with 100+ internationally advanced instruments (e.g., NMR, HR-MS, HPLC), supporting end-to-end research from molecular analysis to physicochemical characterization.

2. Research Team  

- A core team led by Ph.D.-level scientists, operating under the Quality by Design (QbD) principle to establish a systematic R&D platform enabling seamless transition from candidate compounds to commercial production.

3. Academic Achievements  

-To date, the organization holds 50+ authorized patents and has led or actively contributed to the development of three international standards; its technology transfer success rate exceeds 80%.  

Quality and Compliance System 

1. International Certifications

- Accredited as a certified reference material producer under ISO/IEC 17034 by ANAB (ANSI National Accreditation Board).  

- Certified to ISO 9001 for quality management systems by SGS—the world’s leading inspection, verification, testing, and certification company.  

2. Data Integrity Management

- Robust experimental record-keeping and electronic data management systems are implemented in strict adherence to ICH guidelines and the requirements of major national pharmacopoeias, ensuring consistent product quality, traceability, and regulatory reliability.

Corporate Vision

Guided by the mission Making Pharmaceuticals Safer, we are committed to transforming the pharmaceutical reference material industry from experience-based to data-driven practices—and empowering China’s pharmaceutical sector to evolve from global followers to innovation leaders.

※ Customers

1. Government agencies: China Food and Drug Inspection Institute, local quality supervision and inspection institutes, environmental monitoring stations, etc.;

2. Universities and research institutes: China Pharmaceutical University, Shenyang Pharmaceutical University, Sichuan University, Peking University, Hong Kong University, Hong Kong University of Science and Technology, Chinese University of Hong Kong, Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences, etc.;

3. Manufacturers: Hengrui Pharmaceutical, Yangzijiang Pharmaceutical, Qilu Pharmaceutical, Northeast Pharmaceutical, Kelun Pharmaceutical, Yiling Pharmaceutical, Shanghai Pharmaceutical, Harbin Pharmaceutical, Shiyao, etc.

Core team:

Dr. Wenfei Tan
Chief Technical Advisor

2001 Ph.D. in organic chemistry from Lanzhou University

2002-2005 Postdoctoral fellow at the School of Chemistry, Cardiff University, UK

2005-2006 Deputy Chief Researcher of Shanghai WuXi AppTec New Drug Development Co., Ltd.

2006-2008 Associate Professor, Peking University Shenzhen Graduate School

2008-2015 Director of Synthesis, Tianjin WuXi AppTec New Drug Development Co., Ltd.

2015-2017 Director of Chemical Synthesis of Shijiazhuang Yiling Pharmaceutical Co., Ltd.

2017-2019 R&D Director of Sphinx Drug Development (Tianjin) Co., Ltd.

2019-2022 R&D Director of Chengdu Guowei Biopharmaceutical Co., Ltd.

Highlights: Rich professional knowledge and experience in organic synthesis experiments, Strong ability to conduct research independently, Familiar with multi-step organic synthesis technology, Optimization of reaction methodology, Good at compound synthesis design and total synthesis of natural products, Application various analytical techniques (HPLC, GC, NMR, MS, etc) to analyze experimental results, Have strong expression and communication skills, Good interpersonal relationships, management skills and teamwork spirit.

Dr. Yang Li
QCS R&D Director

2007-2011 China Agricultural University Applied Chemistry

2011-2017 Graduated with Ph.D. in Chemistry from Peking University

2017-2021 Assistant researcher and postdoctoral fellow at Peking University

2021-present R&D Director of Shenzhen Jiangchuan Pharmaceutical Technology Co., Ltd. (QCS)

Dr. Chuanbo Yang
QCS R&D Product manager
1996-1999 Graduated from Xiamen University with a master's degree in catalytic chemistry

1999-2006 Lecturer in the Basic Department of China Pharmaceutical University

2006-2009 Graduated with Ph.D. in University of Chinese Academy of Sciences

2010-2012 Process R&D Department of Shenlong Pharmaceutical (Changshu) Co., Ltd

2012-2013 R&D Department of Yantai Dongcheng Biochemical Co., Ltd

2014-2016 R&D Department of Nanjing Jiechuang Pharmaceutical Technology Co., Ltd

2016-2017 Production Department of Yantai Jiaxin Chemical Dyes Co., Ltd

2018-2022

Quality inspection director of Kenoco (Taizhou) Pharmaceutical Research and Development Co., Ltd

2022-present 

Product Manager of Shenzhen Jiangchuan Pharmaceutical Technology Co., Ltd. (QCS)