Hopkins MedTech Compliance

Hopkins CRO initially focused on the clinical trials and FDA applications for COVID-19 antigen self-test kits, integrating clinical institutions in the United States to conduct clinical trials and registration certification for China's IVD enterprises.Hopkins CRO also provides FDA consulting services, including EUA applications, medical device 510(k) submissions, U.S. clinical trials, over-the-counter drug registration, FDA company registration, FDA U.S. agent services, FDA quality systems, U.S. market planning, and the establishment and operation of U.S. sales companies, among other services.Currently, Hopkins CRO serves more than 30 IVD enterprises in China, covering several leading IVD companies with projects including COVID-19 antigen self-test kits, early cancer screening, and more. In the area of COVID-19 antigen self-test kits, Hopkins CRO has conducted over 15,000 cases across 13 clinical sites in the U.S. The company also has multiple clinical sites for monkeypox virus detection kits.Hopkins CRO has established a club focused on European and American market and clinical consulting, providing Chinese IVD and medical device companies planning to enter the European and American markets with domestic and international industry consulting, policy interpretation, customs data analysis, global pandemic and emerging infectious disease updates, new product and technology information, FDA regulations and the latest clinical trial materials, and capital trends. It also shares the company’s extensive experience in helping Chinese enterprises develop overseas markets in terms of quality control, regulation, certification, and clinical operations, offering pre-clinical testing evaluation services in Europe and America, fully supporting the international expansion of domestic enterprises.