Regulatory responses
Regulatory responses and communications involve responding to safety requests from regulatory authorities and communicating important and urgent safety information identified by the marketing authorization holder to regulatory authorities.
Navigating complex regulatory landscapes with regulatory responses and communications ensuring compliance and strategic responses pertaining to benefit-risk profile of therapies.
Regulatory communications
Qinecsa supports our clients in the preparation and submission of comprehensive regulatory communications such as emerging safety concerns, aggregate reports, updated risk management plans, and updated labelling documents.
Regulatory responses
Our team of expert scientists and physicians support evaluation of additional safety data such as broader ICSR data and medical literature to respond to regulatory requests pertaining to new safety concerns.
Importance
Regulatory responses and communications are key when handling drug safety to ensure potential health risks in which a therapy could pose to patients are identified and thus acted upon in a timely manner.