Regulatory Labeling
Regulatory Labeling
Reg Solutions offers end-to-end drug Regulatory labeling services and software support for global and regional Regulatory labeling management, professional assistance in drafting Investigational Brochure (IB), Developmental Core Data Sheet and Developmental Core Safety Information, creating and updating Company Core Data Sheet (CCDS), core to a local product labeling requirement, etc.
Our team of highly qualified medical experts tracks the status of the data sheets’ implementation in local labels, reviews and suggests changes to the data sheets, and drafts the clinical overviews of product labeling requirements for submission to the Health Authorities.