Therapak is a global supplier of pre-packaged convenience kits and procedure packs for the clinical trial, pharmaceutical, diagnostics and clinical laboratory markets. Therapak’s services include: standard and custom component and kit outsourcing; moderate to complex assembly; process control and serial labeling; packaging of courier, medical, diagnostic and pharmaceutical products in a variety of temperature sensitive materials; DOT and IATA certification testing of specimen shipping systems; temperature validation of cold chain products. All product formats are customized to meet customer, regulatory and market-driven requirements.
Therapak has three facilities globally which have been strategically positioned to best serve the outsourcing needs of the laboratory and pharmaceutical community. Facilities are located in Los Angeles, Atlanta and Prague. The Prague facility which represents the newest addition to Therapak’s support structure is well positioned to serve the Eastern European and Asia-Pacific regions.
Therapak’s Quality Management System has been developed in compliance with regulatory standards to meet the needs of our global customer base and to improve the management practices of our company. The quality system operates in accordance to the United States Food and Drug Administration’s current Good Manufacturing Practices for medical devices – 21 CFR § 820; and Article 12 of Council Directive 93/42/EEC concerning medical devices, commonly referred to as the Medical Device Directive (MDD)
The core of Therapak’s services is supported by an experienced project management team. Each customer is assigned a dedicated Project Manager who serves as the Relationship Manager from the point of specifying the scope of services to delivering on the project requirements. In the initial stages of project development, the Project Manager works closely with Business Development and Operations to define the required resources for the project. By program launch, the essential support team will be established and trained on the scope of services. This team consists of the Project Manager, Project Manager Associates, Production Operators, Quality Control Inspectors and Distribution Services personnel.
Production and Inventory Management
Therapak’s VSK Manager software is the central platform used to control production and inventory. The Project Management team administers to the VSK Manager functions involving new product administration, production work orders, stock levels and inventory reorder points. The Distribution Services team controls the flow of inventory into and out of the VSK Manager system. The combination of these administrative functions insures the traceability of products at Therapak by lot number and expiration date throughout the workflow process. The VSK Manager system has proven to be a flexible platform that accommodates both purchased materials and customer supplied materials including project specific documents and manuals.
Online Ordering Systems
Therapak’s PASSPORT™ systems manage a wide range of customer requirements related to clinical trials study management, test specific kit distribution and related bulk supplies shipping and tracking. These systems offer 24/7 access to customer-specific ordering menus that are user name and password protected. Depending on your project needs, there are several easy-to-use PASSPORT systems available to our customers, including PASSPORT™ CTO, PASSPORT™ CTE, PASSPORT™ CSE and PASSPORT™ LSE. Each system includes a perpetual site database, preferred courier integration, mode of shipment selection, customized product listing, lot number and expiration date reporting and package tracking features. The utility of the PASSPORT™ ordering systems to produce management reports has proven to be an accurate financial analysis tool for many of our current customers to access.