New Drug Registration Services
MabPlex’s regulatory affairs professionals have extensive experience in biopharmaceutical new drug registration in China, the United States, and Europe. We design and execute feasible registration strategies according to our clients’ specific goals for each project. Our RDS services include preclinical PK/PD studies, clinical research design and organization, project planning and management, regulatory consultation, and registration. Our professional team can help you reduce unnecessary regulatory risks accelerating the approval process.
The MabPlex registration team’s familiarity with global regulatory affairs minimizes unnecessary risks and accelerates the approval process. MabPlex has established scientific filing templates and integrated new drug registration processes, including document preparation, application filing, registration, manufacturing site verification. Whether you are filing globally or just in China, we are dedicated to providing you with highly efficient and low-cost filing services.
Additionally, our collaborative relationship with the Chinese clinical and non-clinical research institutions allow us to offer a one-stop new drug clinical and manufacturing registration process National Institutes for Food and Drug Control (NIFDC) inspection result monitoring, follow-up communication and coordination with Chinese Institute for Drug Control (CIDC), and supplemental document preparation. These relationships have allowed MabPlex to successfully file new drug applications for our clients who file for IND and commercialize biopharmaceuticals in China.