Storage

Off-Site Storage

We offer a full range of environmentally controlled storage (e.g., Controlled Room Temperature, 2°C-8°C, -20°C, -80°C, and Vapor Phase Liquid Nitrogen) in our restricted access facilities for your GLP, GCP, GMP, and Healthcare material. Our facilities feature back-up equipment and power sources to provide resiliency and can be used as a designated disaster recovery or pandemic stockpile site.
Logistics

GXP Bio offers technicians trained and licensed in regulatory compliant packaging and global distribution of hazardous, radioactive, secure cold-chain and/or controlled substances with applicable permits and chain of custody documentation.

BioSys Technology
We offer flexible digital indexing for all client material using proven SOP’s, embedded quality control procedures, and a validated inventory management system to ensure the accuracy of your inventory, facilitate discrepancy resolution, and standardize your centralized or custom material management program. Our validated material management system provides secure online access to manage your inventory, submit work requests, and generate standard or custom reports.

Life Cycle Management

TBD

Processing

We offer flexible digital indexing for all client material and a validated regulated material management solution (i.e., BioSys™) to ensure the accuracy of your inventory, facilitate discrepancy resolution, and standardize your program to achieve operational excellence. Our validated material management system provides secure online access to manage your inventory, submit work requests, and generate standard or custom reports.
GXP Bio offers technicians trained and licensed.

Distribution

We can consolidate and store your regulated supply chain, intermediate, and finished products in our facilities and coordinate the logistics required to meet your business requirements.

Secure Disposal

We can also assist you in the full lifecycle management of your regulated material when secure disposal is needed. We can assist you to consolidate material at our facilities, verify inventory designated for disposal, and prepare documentation necessary to transfer and incinerate regulated material.

GLP Storage

Our trained specialist in regulated material management logistics, consolidation, processing, storage, distribution, and secure disposal can assist you in managing the lifecycle of your GLP test articles, wet tissue, paraffin blocks, microscope slides, study samples, temperature critical animal reproductive samples, and paper data (e.g., study/patient records, IND submittals, retired study system records created for archive retention, and quality assurance data) at our off-site location or on-site at your location.

GCP Storage

We can store your master cell lines, patient consent forms, investigational drugs, clinical trial samples, human toxicology and pathology samples, and paper data (e.g., master study records, patient records, NDA/BLA submittals, retired clinical trial system records created for archive retention, and quality assurance data) at our off-site facility or assist you in managing them at your location.

GMP Storage

Our trained specialist in regulated material management logistics, consolidation, processing, storage, distribution, and secure disposal can assist you in managing the lifecycle of your GMP master cell lines, stability samples, finished products, product recalls, product legal holds, paper material (e.g., CMC records, batch records, packaging samples, and quality assurance data) at our off-site location or on-site at your location. We also offer off-site GMP disaster recovery plan capacity.

Healthcare Storage

Healthcare facilities need to manage a growing amount of pathology tissue, paraffin blocks, microscope slides, temperature critical research samples, and paper data (e.g., patient records, quality assurance data, research data). GXP Bio offers compliant off-site storage for this regulated material in a full range of environments and trained specialist to assist you with logistics, standardizing inventory packaging, distribution, and secure disposal.

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