CLINICAL SUPPLIES MANAGEMENT HOLDINGS, INC.
- Service Details
Whatever your labeling challenges are, CSM can meet your exact protocol needs by providing unique and customizable solutions. We work with each client to aid in text creation and product design while ensuring patient compliance.
Service providers with expertise in product packaging, labelling, cold chain storage, and temperature controlled warehousing, in-bound and out-bound temperature-controlled shipping, helping you overcome all the challenges of import & export regulations. The system also provides for services like Full Reconciliation Services, Certified Destruction of Hazardous and Non-Hazardous Material, Worldwide Returned Drug Accountability and Management, Virtual Returns, Temperature-Controlled Returns (CRT, Refrigerated, Frozen), Cryogenic shippers, DEA Vault, Safe and Cage etc. Clinical product packaging, labeling and product design efficiently navigates challenging local import and export regulations for on-site delivery of investigational products and supplies. International Conference on Harmonisation (ICH) - and Good Manufacturing Practice (GMP)-certified contract warehouses can be found in any major country. Lifecycle management involves clinical supply management from bulk buying through reconciliation and destruction and also vendor management. Leading providers of Clinical Trial Material management services, including primary and secondary packaging, labeling, distribution and returns, for pharmaceutical and biotechnology companie provide services ranging from Primary and secondary labelling, Secondary packaging/design, Cold chain distribution, Long-term storage, Primary packaging of solid dose forms, Returns, reconciliation and destruction Advanced inspection software, full in-house print capabilities, translation and regulatory approval management process, centralized web-based document management/routing platform, are specifically designed to reduce the overall label cycle times. After a clinical drug product is manufactured by a CMO, it is usually bulk packaged and often sent to a clinical packager for labelling and packaging into patient kits suited to the design of the study. Some large CMOs may offer clinical packaging and distribution services, which give them the advantage of having a ‘one-stop shop’. Other CMOs can add value to their services by partnering with a clinical packager to offer a more comprehensive solution. Packaging Validation and Shelf Life Testing are essential components of your sterility assurance program. These tests ensure that sterility is maintained when a device is sealed in a package until expiration. These tests comprise of Accelerated Aging, Barrier Properties, Biocompatibility, Bubble Emission, Burst Testing, Dye Penetration, Gross Leak Test, Gurley Porosity, Packaging Conditioning, Real Time Aging, Seal Tensile Strength, Sampling Plans, Shipping Simulation, Vacuum Leak, Visual Inspection and Liquid Microbial Immersion etc.
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