The Apeloa Analytical Testing Center (AATC) is a CNAS-certified laboratory complying with cGMP. It leverages strategic resource allocations, a professional technical team, and an established quality management system to provide scientific, accurate, efficient, and safe analytical services to Apeloa's R&D, production departments, and external clients. Established in December 2021, the 3500m2 facility houses an analytical testing team of over 30 scientists. The center's platform advantages including:
Compliance
• CNAS certified
• Audited by National Drug Administration Agency (NMPA)
Efficiency
• Rapid service response
• Extensive project experience
• Short testing turn over time
The AATC's team comprises over 30 members, with more than 30% holding a Master's degree or higher. The quality and technical management personnel have over 10 years of experience in pharmaceutical quality standards and analytical method development. They are well-versed in domestic and international pharmaceutical quality regulations and technical standards. The team has extensive experience in areas such as unknown impurity identification, genotoxic and nitrosamine impurity studies, structural characterization, polymorphism studies, elemental impurities, and quality research for innovative and generic drugs.
AATC's team have successfully completed nearly 100 projects involving genotoxic impurity studies, polymorphism studies, elemental impurities, structural characterization, and other drug quality research work, developing over 500 methods. This has accelerated the clinical research and domestic/international marketing approval of drugs.
