Pharmascience Chooses Software from Adents to Ensure European FMD and US DSCSA Serialization Compliance Regulations
Canada-based Pharmaceuticals Manufacturer selects Adents for its Solution Flexibility, Quality Process and Project Management Expertise.
Pharmascience Inc. is a full-service privately-owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 60 countries. The company, headquartered in Montreal, is the largest pharmaceutical employer in Quebec with 1,500 employees and the 4th largest manufacturer of over-the-counter and generic drugs in Canada.
Pharmascience has chosen to partner with Adents, a leading provider of versatile and easily deployable serialization and track-and-trace software solutions, to assure compliance with the European Falsified Medicines Directive as well as the U.S. DSCSA serialization regulation. Adents Prodigi Cloud serialization solution will bring to Pharmascience the capability to connect with their partners as a Marketing Authorization Holder (MAH) or a virtual Contract Manufacturing Organization (CMO).
Adents Prodigi offers a Certified Gateway to the European Hub providing a valuable service for US and Canada-based companies.
Adents Prodigi’s connection to the EMVO (European Medicines Verification Organization) was a key differentiator in the vendor selection for the Pharmascience serialization project team. Indeed, since February 9, 2019 MAHs that commercialize drug products distributed in the EU Falsified Medicines Directive’s (FMD) jurisdiction are required to upload their product serialization data to the European Hub. Reporting to the European Hub entails generating and managing serialization data compliant with each target country market.
Adents Prodigi enables companies to achieve traceability and documentation compliance easily, addressing both current and emerging regulations. An ideal “standardized software” approach, Adents software is extremely flexible, scalable, and quick to deploy with its configurable connections to any existing 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 Pharmascience’ s team.
“One of the reasons we chose Adents is because of their business model which offers multiple types of connections to partners” said Todor Nyagolov, Head of CEE Licensing & EU Supply chain at Pharmascience. “Adents’ project team was extremely efficient, setting up the solution in less than 3 months including the connection to the EMVO and the validation and qualification process”, “we are now expanding the collaboration to our affiliates and various business units”
“We are so pleased Pharmascience will be using Adents Prodigi software to help them comply with EU,” said Julien Faury VP of Operations of Adents, “and are confident the company will quickly see evidence of the effectiveness, flexibility and ease-of-use of our solution.”
About Pharmascience Inc.
Founded in 1983, Pharmascience Inc. is a leading manufacturer and marketer of prescription generic, over-the-counter, and behind-the-counter products as well as FDA approved Canadian-made injectables. The company commercializes nearly 300 product families in 20 different dosage forms for over 2,000 products. In Canada alone, more than 45 million prescriptions a year are filled with Pharmascience products. Pharmascience, through its Royalmount Laboratories division, also specializes in contract research services.
In 2018, the prestigious Forbes magazine ranked Pharmascience Inc. among its list of top 300 employers. Pharmascience Inc. has strong long-standing philanthropic ties with its communities, both locally and internationally. For more than 20 years, Pharmascience has been working through Health Partners International of Canada (HPIC) as a partner of choice to increase access to medicine. Pharmascience’s total donations of essential medicine is close to $70 million.
For more information, please visit www.pharmascience.com
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