Is the medical cso company legal?

The medical CSO company is legal, but it must obtain the corresponding qualification certificate. The certificate is authorized by the State Administration of Medical Products, which proves that the company has the ability and conditions to carry out clinical research services. Enterprises engaged in medical CSO business without authorization will face legal risks.

Medical CSO (contract sales organization) refers to a business model in which pharmaceutical enterprises entrust third-party organizations to provide professional services such as sales and clinical trials. This model can help enterprises reduce costs and enhance market competitiveness. In China, medical CSO companies must obtain corresponding qualification certificates and abide by relevant national laws and regulations. The medical CSO qualification certification institution authorized by the State Administration of Pharmaceutical Products is China Medical and Health Care Products Registration Management Center. Local drug supervision departments will also conduct supervision and approval according to the location and business scope of the enterprise. Enterprises engaged in medical CSO business without authorization will face legal risks. Relevant laws and regulations clearly stipulate that enterprises that have not obtained qualification certification should bear legal responsibility for engaging in clinical trials and other medical services, and may even be identified as criminal acts.

How does medical CSO company ensure the safety and reliability of clinical trials? Medical CSO companies must formulate standard operating procedures (SOP) according to regulations, which is of great significance to ensure the quality, safety and reliability of clinical trials. In addition, the medical CSO company needs to establish a good cooperative relationship with the client, improve the management mechanism, and ensure the accuracy, truthfulness and completeness of the data.

Medical CSO companies can conduct business legally under the premise of observing laws and regulations. However, due to major experiments in the medical field, we must strictly abide by laws, regulations and industry standards to ensure service quality and safety. When choosing a pharmaceutical CSO company, enterprises and investors need to be clear about their qualifications and whether they have the corresponding management and service capabilities.

Legal basis:

Article 38 of Chapter IV of the Drug Administration Law of People's Republic of China (PRC): Institutions engaged in clinical trials of drugs shall meet the conditions and requirements stipulated by the state and be examined and approved by the drug supervision and administration department.