We deliver all labeling components, data, IFUs compliant to FDA and EMA Regulations. GxP set and used by client teams are followed for all documentation support. Team has strong working knowledge of 21 CFR Part 801, 809, 830, 820 and other rules followed for material handling and disposal in EU.
We carry a legacy of successful deliveries of UDI, GS1, GUDID projects. Designer are strong with knowledge of Branding Guidelines, Visual Communication & Graphics Tools. We have experts on Artwork & Labeling Data Management Systems like enLabel, Kallik, i4i and Creative Cloud.
Pharma & Medical Devices Labels and IFUs are most critical deliveries from quality perspective. We offer manual & automated (through Art Proof, DocuProof) proofing services. We follow stringent quality processes and SOPs. Also various metrics are tracked for quality improvements.
Clarity of contents, fonts, images & artworks are maintained across labeling components. We are experienced in IFU / Manual authoring and translation management in 38+ global languages. End-to-end delivery starts from content management, approvals, reference tracking till production printing.
Pharma & Medical Device Labeling
Parimiti offers expert team of designers and document specialist for all your Pharma and Medical Devices Labeling needs. We are experienced in FDA and EMA regulations that applied to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. 21 CFR Part 801, 809, 830, 820 are followed by our team for US market. Our experts on UDI, GS1, GUDID project rollout are now supporting to EU-MDR requirements. Services we offer:Package Labeling: Primary, Secondary, Shippers, Overlay, Pouches, Barcodes lable design, proofing, version control, coordinating with pre-approved print supplier and managing source of truth in quality system for future reference. IFU/Manuals : Document authoring, content control, version control, proofing, artworks, review and approvals, managing source of truth in quality system for future reference.
Parimiti offers end-to-end Labeling Services for Production as well as New products with close coordination with R&D, marketing, Legal, Regulatory Affair, Quality, Manufacturing and Supply Chain funcions.