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Don’t Let Serialization Laggards Put a Drag on Your Business

By July 20, 2016March 2nd, 2021DSCSA, Serialization

The pharmaceutical industry runs on partnerships. The manufacturer owns one part of the process, while the contract manufacturing organization (CMO), third-party logistics provider (3PL), and distributor all own other parts. Everyone is dependent on each other, and a snag at one point in the process will create problems that branch out in both directions of the supply chain. Of course, contracts and agreements are in place to minimize those problems: Everyone agrees on responsibilities and schedules and gets to work. In most situations, things run harmoniously. But DSCSA requirements are straining some of these relationships.

This isn’t surprising, really. The implementation of any new process – especially one as complex as serialization – is vulnerable to what’s called the Innovation Adoption Lifecycle: A bell curve that runs from innovators and early adopters to laggards – those who get an early start to those that put off the inevitable until the last minute.

So, are laggards negatively impacting your business? Let’s look at how to know for sure if you’ve got a laggard for a partner, and what you can do about minimizing the damage they can do.

Common Partner Compliance Problems – and How to Tackle Them

We’re about 15 months away from November 2017, the DSCSA’s serialization deadline. At this point in time, my educated guess is that about 50 percent of the industry has implemented or are currently working on implementing serialization. We can place those folks on the left half of the bell curve – they are innovators, early adopters, or early majority. But that leaves the other 50 percent. These late majority and laggard companies are at risk of missing the deadline. (If that’s you, call us today: LSPediA can still help you reach your goals and minimize the business impact of non-compliance.)

Below are five situations you need to watch for:

A: Your MAH partners or customers have not mentioned anything about serialization to you.

B: Your CMO hasn’t asked about serialization and now they are avoiding your inquiries or not communicating altogether.

C: Your CMO is just beginning serialization, but they don’t have a clear plan for meeting the deadline.

D: Your CMO  is going through a merger, acquisition, or reorganization, and you’re concerned that their serialization plan might suffer as a result.

E: Your CMO denies it, but you are quite sure they won’t be able to meet the serialization deadline.

In the end, what you want is serialization compliance, which may require some concessions or extra effort on your part in order to meet the deadline. Just beware of stretching yourself too thin or giving up too much in the way of time and resources.

How LSPediA Can Help

If your business is at risk due to partner serialization delays or non-compliance, LSPediA Advisory and Consulting services can help. We offer pharmaceutical manufacturers, CMOs, 3PLs, and distributors large and small a variety of services, including:

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

Contact me to today to find out how we can provide risk mitigation, independent validation, and oversight for your serialization projects.

 

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.