Huayaoketron is a CRO+MAH company offering comprehensive life cycle management services for pharmaceuticals and medical devices. Our core competencies lie in three key areas: pharmaceutical research, clinical research and MAH management. We are a market leader in a number of fields, including API research, pharmaceutical formulation research, human bioequivalence testing, phase I-IV clinical research for pharmaceuticals and devices, large and small molecule biosampling and MAH management.
We have been engaged in pharmaceutical research for 20 years, with a laboratory area of more than 6,000m² in Shenyang and Zibo. The laboratory is operated and managed in accordance with the relevant standards of the China National Accreditation Service for Conformity Assessment (CNAS). Our research activities focus on generic drugs and improved new drugs. To date, we have completed more than 300 studies on APIs, generic drugs and innovative drug formulations.
We have been engaged in clinical research for 16 years, with a team distributed across nearly 30 provinces and cities in China. We have completed more than 300 human bioequivalence trials, more than 200 phase I-IV clinical trials, and more than 400 large and small molecular biosample analyses. The projects span 80% of therapeutic areas and have amassed a wealth of hospital and expert resources. Four phase I clinical trial wards have been constructed, and we have collaborated with over 600 GCP hospitals in China and more than 300 member hospitals of the former China GCP Alliance.
We have been engaged in MAH management for six years. Based on a core project system with clear commercialisation ideas and a stable supply chain, Huayaoketron fully integrates the resources of pharmacy and clinical CROs, supply chain platforms, and the commercialisation of pharmaceuticals and devices. This creates an MAH model for the whole life cycle management of pharmaceuticals and devices by means of a project management system aimed at commercialisation.
Our team has a proven track record of success in major pharmaceutical special research projects organised by the state. The laboratory has also consistently passed the capacity validation work organised by the state. We have served more than 300 pharmaceutical and medical devices companies and have successfully completed numerous projects. Our goal is to become an excellent pharmaceutical products and services provider,we will continue to adhere to the following principles: innovation, integrity, learning, high efficiency and project management. We will also continue to integrate internal and external high-quality resources in order to build a full-life-cycle service ecosystem for pharmaceuticals and devices.
