The Submission Dossier Regulatory Affairs in Latin America
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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…
Registration and post-approval variation of pharmaceutical drugs in Latin America: challenges and opportunities, Journal
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Manager Regulatory Affairs Resume Samples
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Regulatory Affairs
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Regulatory Affairs Manager Resume Samples
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Frontiers Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region
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Regulations: Central and South America - AgriBusiness Global
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Regulatory Affairs - Pharmaceutical Technology
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CMC Requirements for New Drug Registration in Latin America
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PDF) REGULATORY REQUIREMENTS FOR REGISTRATION OF GENERIC DRUGS IN “BRICS” COUNTRIES
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PDF] A comprehensive study on regulatory requirements for development and filing of generic drugs globally