Business Information
The group's principal activity is to provide publishing services. The group provides eCTD readiness assessment & gap analysis, eCTD training targeted at company leadership, regulatory strategists, regulatory operations, IT, eCTD quality control & validation for all ICH regions, eCTD publishing systems selection, implementation and validation, EDMS publishing systems selection, implementation and validation, eCTD submission publishing services, eCTD submission publishing staff augmentation, electronic Document Management System (EDMS) selection, implementation and validation, MS Word templates, toolbars, and user training for eCTD document authoring, EndNotes implementation, configuration, and training, Label conversion to Structured Product Labeling (SPL) standards for drug, biologic, device, veterinary, and over-the-counter products. The group operates from the United States.
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