DSCSA compliance

Virtual Manufacturer Praises OPTEL’s Best-in-Class Support

Selecting a serialization software provider and implementing an enterprise solution can be a complex process. Not only do pharma companies have to assess several providers, but they also must gauge the project, coordinate with numerous partners, complete validation processes and have a system running before the legislative deadlines. All of this can be even more overwhelming if your company is unfamiliar with the ins and outs of serialization legislation and the unit-level serialization process overall.

OPTEL understands the challenges start-up pharma companies and virtual manufacturers face. In fact, we designed our implementation process with true end-to-end support, a major benefit for small to mid-size pharma companies that don’t always have dedicated resources. Our complete service offerings and in-house subject matter experts help our customers successfully navigate all phases of the serialization process—scoping, planning, design, validation, launch, account management and ongoing support.  But don’t take our word for it—see what our customer, Aytu Bioscience, has to say.

Aytu Bioscience, Inc. (AYTU) is a Colorado-based life-sciences company that specializes in hypogonadism, male infertility and sexual wellness. Aytu vetted multiple serialization software solutions, and selected OPTEL’s Verify Brand Software® based on our industry expertise and on-going support.

“During our selection process, OPTEL’s leadership went above and beyond, investing considerable time with us as we evaluated our options. They were able to offer valuable insight by further educating us on serialization and compliance and ultimately worked with us to build a plan for our long-term success,” said Aytu BioScience director of commercial operations, Kristi Bruce. “Since we are a start-up, this type of knowledgeable assistance speaks volumes to their abilities and corporate culture.”

With OPTEL’s support, Aytu will begin its implementation process to meet the DQSA compliance deadlines. In addition to end-to-end implementation and validation support, our team will fully train Aytu to use the Verify Brand Platform for reporting and compliance purposes and will also provide platform administration and ongoing support throughout the length of our partnership.

“We are still in the implementation phase as we set up our serialization software, but we are pleased with OPTEL’s efficiency and continued support,” said Bruce.

In addition to helping Aytu meet its compliance deadlines, the Verify Brand Software will also allow the virtual pharma manufacturer to utilize the serialization data it captures to track each individual product through the supply chain while providing real-time insights and easy-to-read reports.

Are you a virtual manufacturer looking for a L4 serialization provider? Send us a note, and learn about how our proven solution can help you reach compliance.


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