News | August 1, 2008

Generic Pharmaceutical Manufacturers Can Now Outsource With Confidence

image1

For an industry where time to market is always a critical component of success, outsourcing is an issue for generic drug manufacturers that becomes more important with each passing day. Thanks to the availability of the Precise Data GL-AMS Global Artwork Management System, there's now a way for generic drug makers to outsource successfully with an application-specific, streamlined process management solution for packaging design and approval. What's more, the GL-AMS system can incorporate input from multiple stakeholders within a global enterprise and from outsource partners with minimal ramp-up time.

"Once a drug comes off patent the window of opportunity to secure own-label manufacturing contracts is naturally very tight and success is contingent on how fast a manufacturer can put a fully packaged, fully compliant product on the drugstore shelves," explains Alan Leamy, Chief Executive Officer, Precise Data. "This challenge is exacerbated by the complexity of the product and also the stringent compliancy requirements. The GL-AMS Global Artwork Management System quickly and seamlessly brings outsource partners into the control and collaboration loop, enabling generic pharmaceutical manufacturers to take on extra capacity with greater ease and confidence!"

Precise Data's GL-AMS Artwork Management Solution is custom-designed for the generic drug manufacturing market and is uniquely able to securely integrate input and approvals from multiple parties inside and outside the enterprise in a way that provides real-time intelligence on where in the supply chain a packaging property may exist at any one point and time. With multiple internal and external participants, the need to seamlessly localize packaging projects for discrete markets and regulatory spheres is critical.

"Now, if a GL-AMS customer does not have the capacity to meet the packaging requirements for an own-label manufacturing contract, they can quickly and seamlessly integrate third artwork creation companies into the production cycle with greater confidence than ever before possible," Leamy continued. "GL-AMS allows our customers to outsource with confidence that the marketing information, product information and regulatory information are correct and approved, eliminating considerable risk from the process."

GL-AMS creates a central online storage area that accepts all files using recognized industry standards, to provide a single central repository for a companies digital artwork assets. GL-AMS integrates with all aspects of the artwork lifecycle according to and in compliance with relevant industry standards and the customer's specific needs. GL-AMS provides generic pharmaceutical manufacturers with unique customer benefits that include: time savings that eliminate delays for signed off proofs, ownership with electronic signatures that provide an audit trail and accountability, control that allows users to stop and start production to suit manufacturing capacities or last minute regulatory changes, compliance that is developed in line with GMP and FDA guidelines, flexibility that provides new or temporary outsource vendors with controlled access to artwork collateral when capacity is an issue, and real-time decision making made possible by the fact that the entire system solution is hosted from the Internet. All of the above can be achieved with input on a global scale to eliminate the need for decision makers to be in house via Secure Remote Web Access.

Also, because GL-AMS exists on a secure Internet site - as opposed to issuing physical hard copy or soft copy via courier - manufacturers can quickly assign print projects to new print suppliers without the need to acquire properties from previous suppliers and there are also savings on logistics and project time.

"It's not always easy getting your art properties returned by former print suppliers," Leamy explains. "There's naturally less of a rush when there is no business incentive attached. GL-AMS retains access to the finalized print product and this makes generic drug manufacturers swifter and more versatile to work with a range of outsource partners!"

About Precise Data
Precise Data is a member of the Perigord Group, which specializes in providing workflow solutions and localized packaging and pre-media artwork management services to global blue chip companies in the pharmaceutical and IT industries.

While headquartered in Dublin, Ireland, Precise Data also maintains a United States base of operations in Branford, Connecticut and an Asian base of operations in Singapore. More information about Precise Data can be obtained by email at peter.schmitt@montesino.com.

SOURCE: Precise Data