Skip to main content

Coordination and Preparation are the Keys to Serialization Success

By June 8, 2016March 16th, 2021Company News, DSCSA, Serialization

What is serialization preparation looking like at your organization? If you’re like most small- to mid-sized pharmaceutical manufacturers and distributors, you are (or will be) relying on an internal team of people to get the job done. And most of those team members still have their regular jobs to tend to in addition to working on the implementation project. That may worry you, but it shouldn’t. Because I can tell you from experience that the difference between successful serialization implementation and troubled serialization implementation is less about time and more about knowledge.

Whether you’ve begun the process or not, that team probably has a lot of questions about how serialization implementation will impact your business, such as:

  • With so many moving parts, how can we be sure everything will fall into place by the deadline?
  • Will our CMO serialization meet distributor requirements?
  • What if the FDA delays the effective date, and how will that impact all of our other internal and external deadlines?
  • Will the unserialized inventory we manufacture prior to the deadline be accepted by distributors given the three-year expiration window?
  • Do we need EPCIS to manage serialized data and data communications?
  • If we outsource distribution to a 3PL, do we need an EDGE warehouse system?

Most businesses find that getting answers to these kinds of questions from resources inside the company is close to impossible. Which means it may be time to turn to a consultant.

LSPediA Advisory Services: Access to Our Experience, Every Step of the Way

Every day, we provide clients with answers to questions like those above – and make them aware of questions they never thought to ask themselves or their partners.

Starting from as little as $1000 a month, LSPediA Advisory Services include:

  • The Serialization Toolkit base bundle
  • Unlimited access to us for answering questions
  • A guided monthly meeting
  • Recommendations on strategy, planning, roadmaps, technology, and vendors

By signing on with our Advisory Services, LSPediA customers leverage our deep experience and documented track record of successfully managing serialization implementation for manufacturers and distributors large and small. Benefits include:

  • Risk mitigation: We alert you to potential mistakes, and help you overcome setbacks
  • Objective, independent validation: We tell you what you’re doing right and help you fine tune your processes
  • Oversight: We help you keep internal teams productive and effective, maintain timelines, and achieve goals

In addition to our monthly Advisory Service, we also offer extended consulting services, any of which can be added on at any time. These LSPediA-led offerings include:

  • In-depth strategy development and roadmap creation
  • Vendor selection and management
  • Line execution services
  • Technology implementation
  • CMO serialization
  • 3PL serialization
  • Comprehensive project management

Get Started Today

The time to begin serialization is now. Working with LSPediA means you have a partner with deep experience and a complete understanding of the entire serialization process. Starting for as little as $1000 a month, we can give your company compliance piece of mind – and a competitive edge. Contact us today.

 

About LSPediA

LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.