Quality Assurance

Noahpharm’s quality management system focuses on control of study specific risks, and ensures data integrity and subject protection and safety. In accordance with the quality management principles, GCP guidelines and pharmaceutical regulatory requirements, we follow the company policy and project control requirements and establish the complete operation department’s standard operation procedures (SOP) and quality management systems. Our quality assurance system ensures the protocol compliance and identifies quality risks.

Registration Affairs

Noahpharm can provide professional registration services for chemical drugs, biological products and medical devices, assist drug development and shorten the time to market. During product registration, the rich practical experiences enable Noahpharm to precisely grasp product registration essentials. Noahpharm is deeply familiar with the medical product development process and technical requirements, and keeps sound communication with regulatory authorities. Noahpharm maintains efficient two-way communication with customers and regulatory authorities in terms of procedures, regulations and technical compliance to ensure rapid project advancement.

Wang Dandan, RA Director

Graduated from the China Pharmaceutical University
• Had 16-year experience of drug research and development; familiar with the whole life cycle from drug research and development to registration application, and domestic and foreign drug registration laws and regulations. Responsible for all work of project registration application, industrial policy analysis and interpretation;
• Good at organizing, coordinating and integrating project resources;
• During the company’s development and growth, efficiently led the team to complete registration application of 330 varieties and obtained nearly 200 clinical approvals, including over 10 initial applications and over 10 import registrations.

Xie Daosheng, Medical Director

Medical Master, Graduated from the Peking Union Medical College Hospital
• Had over 10 years of medical experience, once worked with many foreign enterprises; participated and completed the medical design of clinical trials of over 10 innovative drugs (Phase I ~ Phase IV);
• Completed writing of protocols for over 70 PK, tolerance and BE studies;
• Participated in studies of over 10 innovative drugs such as Class 1.1 chemical drugs TKI, CDK4/6 inhibitor, T2DM, mainly covering endocrinology, oncology, and respiratory system.

Cao Zhao, Clinical Operation Director

• Had 15-year experience of clinical trial project management and team management, rich project management experience, fully participated in many international multi-center projects in fields of infection, endocrinology, oncology and neurology;
• Has rich resources of medical experts;
• Familiar with the important links of new drug clinical research pipeline;