[Case study]: Achieving the EU FMD regulation and requirements through automated software by SoftGroup
Table of Contents
This customer story discovers how Ecopharm, a Bulgarian leading pharmaceutical company, met the requirements specified under the EU Falsified Medicines Directive (FMD), due to the SoftGroup solution.
Facing the challenges and customer requirements, SoftGroup delivered a customer-beneficial solution that provides transparency and ensures the integrity of Ecopharm products.
Ecopharm is one of the Bulgarian leading pharmaceutical companies in the SME segment. Founded in 2000 as a successor to the German company ASTA Medica, Ecopharm’s product brands are well known and accepted in the Bulgarian market thanks to the combination of uncompromising quality, high efficiency, innovation, and affordability. It owns over 60 medical products as well as around 20 OTC products.
The medications are manufactured by contract manufacturers and delivered to the European Union market. Approximately 150 highly qualified medical and other specialists carry out the company’s activity.
Ecopharm needed a solution to help them meet the requirements specified under the EU Falsified Medicines Directive (FMD) while minimizing operational impacts. Under the FMD, Marketing Authorization Holders have several responsibilities that help ensure the safety and authenticity of drugs as packaging and serialization of drug products, including reporting data to the European Medicines Verification Organization (EMVO).
Ecopharm faced the following challenges in particular:
- Following the EU FMD regulatory and compliance requirements
- Balancing the cost pressure
- Sharing serialization data and reports through a connection to all CMOs (Contract Manufacturer Organizations) eliminates data silos that lead to duplication and confusion.
- Upholding high-security standards
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