CMO Compliance with EU FMD: Time Is Almost Up!

If you’re a contract manufacturer in Europe, you know that time is running out to choose a solution provider to meet upcoming compliance deadlines. Based on our hundreds of conversations with CMOs around the world, we have come away with an understanding about the key features CMOs are looking for in an EPCIS/data management solution.

  • High level of customer service. We cannot overstate the importance of great customer service when selecting a solution provider. With the clock running down on serialisation deadlines, experience, know-how and responsiveness will ensure that your serialisation projects are executed flawlessly. At OPTEL, we’re laser-focused on maintaining a high level of customer service and satisfaction. The continuous addition of qualified, experienced serialisation professionals to our pharma team is a testament to our customer-centric approach.
  • Standards-based connection with trading partners. There’s no way around it: fast and efficient serialisation requires adherence to standards. Not only do standards ensure compatibility, but they eliminate the heavy mapping fees pharma organisations have to pay when solution providers require them to use proprietary networks. OPTEL supports the EPCIS 1.0, 1.1 and 1.2 standards. This support, as well as our support for multiple protocols, allows us to deliver the fastest path to compliance.
  • Ability to handle global serialisation projects. Contract packagers and pharma manufacturers say they’re interested in leveraging serialisation solutions that can help them meet the compliance requirements of the U.S. Drug Quality Security Act (DQSA) and the EU Falsified Medicines Directive (EU FMD), among others. OPTEL is an EPCIS/data management solution provider with the, capacity to support DQSA, EU FMD and emerging global serialisation requirements.
  • Validation support. CMOs are looking for solution providers that can ensure that this important step—installation, testing, protocol execution and documentation approvals—goes smoothly. At OPTEL, we demonstrate our commitment to quality through the comprehensive validation support we provide to our pharma customers.

To cross the compliance finish line faster, with less hassle and with a lower total cost of ownership, pharma organisations should choose a solution provider that is the best possible fit. Look for a combination of broad serialisation experience, a standards-based approach, a flexible platform and excellent customer support—and be sure to ask for references from existing clients that demonstrate best-in-class customer service and validation support.

Since we began servicing our first customers three decades ago, OPTEL has embraced the values of transparency and exemplary customer service. Learn more about why our serialisation and traceability solutions are the best choice by scheduling a demo of our software.