Medical Devices | Labeling Data | Label Design | FDA Compliances
Enterprise labeling domain experts, designers, document specialists, and systems are critical business drivers for large organizations like medical devices and pharmaceutical companies. We offer expertise & services for compliance management, artwork management, enterprise labeling, quality system management, labeling system integrations with enterprise systems like SAP, Oracle, and Quality / PLM Systems like Teamcenter. We are experienced in FDA and EMA regulations that applied to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. All regulations like 21 CFR Part 11, 801, 809, 830, and 820 are followed by us.
We manage all end-to-end labeling tasks for life cycle and NPD(new product development) including but not limited to artworks for Primary, Secondary, Shippers, Overlay, Pouches, Barcodes label design, proofing, version control, coordinating with the pre-approved print suppliers, and managing source of truth in a quality system for future reference. We are experienced in User Manual document authoring, content control, version control, proofing, artworks, review, and approvals, and managing sources of truth in a quality system for future reference.
We have experience on enLabel, Loftware, Adobe creative cloud, and leading automated proofreading software.
