The Regulatory Affairs Department of GoBroad Clinical Research Center provides full drug registration application services throughout the lifecycle of chemical drugs and biopharmaceuticals. Over the product registration application, we precisely identify the key points of product registration, comprehensively understand the specific requirements from regulatory authorities on submission dossiers, and manage the submission from various aspects, including application procedures, technical requirements, etc. We also maintain effective communication and interaction with clients and regulatory authorities to ensure the submission dossiers comply with regulatory requirements, enabling the progress of projects.

Our regulatory services include drafting, reviewing, compiling, submitting, and following up with the submission documents for registration (covering communication meeting with authorities, clinical trial applications, marketing authorization applications, re-registration applications, and supplementary applications).