Laboratoires Théa addresses European FMD and South Korea market regulation requirements with Adents Cloud serialization solution
Leading Ophthalmic Pharmaceuticals Company chose Adents Prodigi to connect with approximately 15 supply chain partners to stay compliant with current and future regulations.
Laboratoires Théa is a 100% dedicated eye care pharmaceuticals company offering a complete portfolio of products – both preventive and curative – in the areas of diagnosis, surgery and therapeutics.
Théa’s products are marketed in more than 70 countries around the world. The company has surpassed the € half billion mark of sales revenue (FY 2018) and boasts more than 1,400 employees worldwide.
Théa has chosen to partner with Adents, a leading provider of versatile and easily deployable serialization and track-and-trace software solutions, to ensure compliance with both the European Falsified Medicines Directive and the South Korean serialization regulation.
Théa’s Management team selected Adents for several reasons, but the ultimate factor was the partnership approach demonstrated during the selection process. Adents firmly committed to working hand-in-hand with the Théa team throughout the implementation and qualification timeline. Théa felt this shared responsibility approach would be most efficient and better prepare them to support their new systems and processes.
Typically, a serialization project is considered an engineering or regulatory/quality project. Most companies soon find that many functions within a company will be impacted by the consequences of a serialization implementation – from packaging operations through customer operations.
Théa’s management team became aware of this structural impact early in the process and appreciated how Adents’ delivery team anticipated the project challenges and proposed solutions.
Moreover, Adents solution has already been successfully deployed at one of Thea’s main CMO’s, this experience was also a key factor in Thea’s decision to select the Adents solution.
Adents Prodigi enables companies to efficiently and easily achieve traceability and documentation compliance, addressing both current and emerging regulations. Adents software is developed using a “standardized software” approach, providing flexibility, scalability, and speed to deploy with its configurable connections to any trading partner.
Adents’ robust Quality Process and Documentation approach was also a key success factor as it drastically shortens the implementation timeline and reduces the validation burden on Théa’s team.
“We were happy to have been through the serialization process with Adents. They worked with us in total transparency all along the project implementation, providing updates on a regular basis and staying committed and involved until the last step” said Isabelle Paquereau, Industrial Operations Director at Laboratoires Théa. “Adents Prodigi is a cornerstone in our serialization strategy. Its flexibility will allow us to be easily compliant with new market regulations and connected with new trading partners. It will help scale up our operations”.
“We are delighted Laboratoires Théa will be using Adents Prodigi software to help them comply with European FMD and South Korean regulations,” said Julien Boisnet Global VP of Sales at Adents, “Moreover, Théa has equipped Laboratoires Bénac, one of its subsidiaries, with Adents Seriza, our line and site level solution as well. They will have the opportunity to experience the effectiveness and flexibility of a full-stack Adents Serialization Suite from Level 1 to Level 5.”
About Laboratoire Théa
Today, Théa is the third eye care group in Europe (not including the retina market). Based in Clermont-Ferrand, the laboratory has continued to expand by opening nearly 30 subsidiaries in Europe, North Africa, North and South America, and also the Middle East. Currently, the Théa group constitutes a network uniting nearly 1 500 members of staff worldwide, with its products available in more than 70 countries. Théa is an independent family group, developed from a Research and Development start-up by Henri Chibret, a fourth generation member of an ophthalmic dynasty. Jean-Frédéric Chibret (a fifth generation family member) has presided over the company since 2008.
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