4.6 (407) · € 22.50 · En Stock
The submission dossier is the packet of documents that are to be submitted to a health authority for registration of a product, or for other life-cycle maintenance activities, such as renewal of registration or CMC variations. The requirements vary very widely from country to country, but in general a dossier contains administrative documents, (such as…
Regulatory Affairs in Latin America
Regulatory Affairs
Drugs, Biologics and Medical Devices Regulatory Affairs Course - Royed Training
Regulatory Affairs - Pharmaceutical Technology
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry by ComplianceOnline - Issuu
PDF) Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product
Brazil's Anvisa Organization of the Common Technical Document (CTD)
External Drivers for Regulatory Outsourcing
Regulatory submission challenges faced by small and midsize organizations