The two companies recently completed the worldwide implementation of a serialization deployment to aid the production, packaging and supply chain of one of the world’s top 10 pharmaceutical firms.
Initially encompassing the U.S., UK, Ireland and Germany, markets where both companies have a strong presence, the collaboration brings together Italian-based SEA Vision’s serialization software along with Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.
“The partnership enables pharmaceutical manufacturing and packaging companies to utilize SEA Vision’s products with added on-the-ground assistance from our expert engineers to ensure they can deal with the continuous challenge that serialization brings,” said Jim Lehane, director, Zenith Technologies. “Given what we’ve already achieved to date in this field and the similarities in our customer base, we are ideally placed to work together with SEA Vision to help clients achieve seamless compliance with the new serialization requirements.”
The deal has been unveiled as drug makers begin to seriously turn their attention to the looming legislation changes. The serialization of licensed drug products will be legally required for companies in the EU from 2019 as per the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation and from November 2017 in accordance with the US Drug Supply Chain Security Act (DSCSA).
Marco Baietti, commercial director at SEA Vision, said, “As a business, we are 100% focused in the pharmaceutical space and are committed to helping companies deal with the challenge of serialization. Following the announcement of the timing for the legislation changes, we have experienced a wave of requests from tier two and three pharma companies. This collaboration is therefore designed to give these firms the tools and skills they require to confidently introduce new systems well ahead of the deadlines.
Aside from traditional pharmaceutical companies producing bulk API and finished licensed products, the partnership will also assist contract manufacturing organizations (CMOs) that also need to adapt to the regulations.