TraceLink has formed a partnership with SPI to help pharma companies meet Brazil's track-and-trace requirements for medicines, due to come into effect from December this year.
Under Brazil's Resolution RDC 54, by December 10 pharma manufacturers are required to have serialised and tracked three batches of product through the supply chain, and a year later this will be mandatory for all pharmaceuticals.
SPI - a specialist in pharmaceutical IT services and automation - will help TraceLink to implement its Life Sciences Cloud platform throughout Brazil, according to the two companies. The full press release can be read below:
TraceLink accelerates adoption of life sciences cloud in Brazil through partnership with SPI
TraceLink Inc., the world's largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced that it has established a strategic partnership with SPI, a leading Brazilian provider employing more than 200 sales and technical support professionals with expertise in pharmaceutical IT services and automation. With the rapidly approaching Brazil RDC 54 Phase 1 deadline of December 2015, SPI will help TraceLink to implement its Life Sciences Cloud platform throughout Brazil, including the company's track and trace solutions that have been tailored to help global and domestic pharmaceutical manufacturers comply with Brazil requirements for serializing and tracking three batches of product at the unique item and transport case level.
"Brazil currently has the most sophisticated track and trace requirements in the world, where manufacturers must capture product movements across the supply chain for both their direct and indirect partners, as well as report all product movements to ANVISA," said Shabbir Dahod, president and CEO of TraceLink.
"Partnering with SPI gives us immediate access to the local market with a seasoned provider that has a 24-year track record of establishing strong relationships with leading pharmaceutical manufacturers in the region. Their expertise in the areas of serialization, project management and technical support will enable us to rapidly expand beyond the 12 global pharmaceutical manufacturers that have already selected TraceLink as their solution provider for Brazil - and extend our market leadership to this top, global pharmaceutical market that has more than 5 billion medicines flowing through its supply chain every year."
Marcos Barbosa, Executive Director, SPI added, "We're thrilled to partner with TraceLink and to help the company expand its international footprint in Brazil by enabling companies in the market to meet these challenging regulations."
"TraceLink's deep global track and trace experience and network for rapidly connecting thousands of pharmaceutical supply chain companies have caught the attention of many Brazilian pharmaceutical companies, who are all seeking cost effective solutions to securely address both short-term RDC 54 deadlines and longer-term compliance requirements. We see a significant opportunity to cultivate the TraceLink brand in Brazil, and widen the company's rapidly growing market share as the pharmaceutical supply chain prepares for the December deadline."
With headquarters in Sao Paulo, SPI employs more than 200 professionals across Brazil with broad expertise in serialization, IT project implementation and management, and technical support. Drawing upon customer knowledge from more than 75 Life Sciences companies in Brazil, SPI is an active contributor to a range of global and local standards organizations, including GS1 Brazil, and regularly provides influential insight and feedback on track and trace best practices and implementation approaches.
In partnership with TraceLink, SPI's local, hands-on staff will work with Brazilian pharmaceutical companies and their trade partners to plan, implement and support the deployment of TraceLink's Life Sciences Cloud platform, including Brazil-enabled serialization solutions; Product Track Brazil, a transaction history management system for capturing all product movements and events across the supply chain; and Brazil Reporting, for delivering required compliance information to ANVISA.