Guangzhou PharmaLab Co., Ltd. (hereinafter referred to as the GPHL) was jointly founded in 2009 by China National Analytical Center of Guangzhou (hereinafter referred to as the NACC)and the team of returned Dr. Jiang Zhijun. It is a state-holding pharmaceutical CRO. The equityrestructuring was completed by the end of 2018. The NACC is the only national analysis andtesting center in South China, which is now subordinate to Guangdong Academy of Sciences; Dr. Jiang Zhijun is a pharmaceutical expert and a member of the Expert Committee of the UnitedStates Pharmacopeia (USP).

Thanks to the excellent background of the founding team, GPHL is operated under the cGMP and FDA 21 CFR 11. All of our instruments have passed 3Q (IQ, OQ, and PQ), and controlsoftware is from Empower 3 to Chromeleon. GPHL is one of the earliest pharmaceutical CRO applied network software. Meanwhile, GPHL has passed the certification of Dun & Bradstreet andis a registered member of the FDA. 

The quality policy of GPHL is “Science, Justice, and Efficiency”.

GPHL has many advanced analytical instruments and pharmaceutical equipment, includingQ-Exactive HF Orbitrap UPLC-MS/MS System, UPLC-MS/MS, ICP-MS, GC-MS/MS, GC-MS, SEM, GC, HPLC, IC, LPA (Laser particle analyzer), dry and wet granulation machine, efficient coating machine, oral liquid filling machine, fluid bed, 3D motion mixer, freeze-drying equipment, performing machine, etc. 

GPHL has a first-class technical service team. The R&D team is led by a research scientist who used to work at the Centre for Biologics Evaluation in Health Canada. The team gatheredmany domestic R&D talents of leading pharmaceutical enterpriser or scientific research institutions. we provide comprehensive one-stop drug R&D, quality research of small moleculechemical drugs (impurity study, gene toxicity study, structure confirmation, methodology development, validation, etc.), quality research of biological drugs (determination of the molecularweight of protein, peptide map analysis, disulfide bond pairing analysis, host cell protein residue analysis, etc.), Extractable and Leachable (E/L) of drug contact material and CCIT (containerclosure integrity test) of injection packaging. 

GPHL was the earliest CRO to provide E/L study services in China, so we have accumulated rich experience in this field about research and compliance test. Meanwhile, we participated in and collaborate in the development of national standards for E/L and CCIT, which contributed to the development of the domestic compatibility and sealing study. 

The company owned dual membership of the technical and standard committee in China National Pharmaceutical Packaging Association (CNPPA) and hired experts from the association as consultants. Till now, GPHL has completed hundreds of E/L and CCIT projects and helped pharmaceutical enterprises to obtain drugs approval, including a spray which is conducted ANDA application in both FDA and NMPA (first ANDA in NMPA), an HIV vaccine which is conducted IND application in FDA, and two new drugs in category 1.1 of China (fospropofol disodium for injection and remimazolam besylate for injection). 

Our vision is to provide a comprehensive drug R&D service platform for pharmaceutical enterprises and create value for customers, which achieve customers meanwhile achieving ourselves and contributing to human health.