Celegence LLC services

Supporting client requirements from creation to maintenance of global and local drug product labeling. Regulatory Labeling regulations are essential for ensuring compliance of drug products to be used safely and with efficacy by patients. However, regulatory labeling compliance requirements can differ across regions and new regulations are routinely being introduced to update labeling documents. Prescription drug labeling includes the core safety and clinical information about a drug product, often in the form of a local regional label for example Summaries of Product Characteristics (SmPC); United States Prescribing Information (USPI) or Product Monograph (PM); or, expressed as a global company core document such as Company Core Data Sheet (CCDS).