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Serialization Checklist: 3 Questions to Ask a Life Science Consultant

By 2020, approximately 90% of prescription drugs were serialized worldwide (Source: R&D). By 2023, life sciences companies across the US will have achieved package-level traceability. In order to meet regulatory mandates, companies should have a defined strategy and be working towards their goal…

But that’s a whole lot easier said than done.

For many companies, operations are complex enough without the added pressure of serialization. This is where a consultancy can help—we can dedicate the time and resources necessary for a transformation of this size.

In fact, when you work with the right consultancy it can—through streamlined implementation, minimized downtime, and focused effort—make the road to success smoother and faster. Which means you will benefit from a competitive advantage over those who are still catching up.

If you do choose to bring in outside help, here are three of the top questions we recommend you ask before deciding who to work with. With so much at stake (potentially millions of dollars) you want to make sure you’re working with a provider who is going to turn your investment into something more than just an exercise in compliance. (Source: Xendo)

1. What can I expect in the first 90 days?

Serialization is a hugely complex task that requires careful planning and continuous oversight to achieve. With the capacity to create a step-change in business efficiency (if leveraged correctly) it’s a transformation that shouldn’t be taken lightly.

With this in mind, you want to make sure you’re putting experienced leaders at the helm of the mission; people you can trust to lead you to success.

A good consultancy should be able to outline what its first moves will be. The answer you get will give you insight into the level of its expertise, industry experience, and how it plans to drive early results.

Within two to four months our clients receive:

• A clear picture of where their business currently stands. This not only allows us to develop a strategy that will minimize disruption, but also highlights areas for improvement.

• An implementation strategy that either kick-starts their serialization efforts, or redirects their previous strategy down a better path

• A list of ‘quick wins’ that we will deliver within 90 days to ensure the project is returning the investment from the get-go.

If you’d like to know more about our serialization approach, you can download our guide ‘How Pharmaceutical and Biotech Companies can Unpack the Complexities of Serialization for a Streamlined Solution’.

2. What return can I expect to see from investment in your services?

The added cost of hiring a consultancy (on top of the cost of serialization implementation) will undoubtedly be a major consideration in the decision to outsource. Close examination of how and if that firm will return your investment could arm you with the information you’ll need to get buy-in from the relevant people.

Our advice would be to listen out for a consultancy whose answer doesn’t only focus on ROI, but also on how they will leverage the opportunities presented by track-and-trace capabilities to drive value long after serialization is achieved.

3. What is your value proposition?

The key to unlocking maximum value from a partnership with a consultancy is synergy—this can be achieved when its approach either compliments yours, or epitomizes how you’d like your business to operate in the future.

By asking this question you can uncover what makes the consultancy tick. For example, our answer to this question would be:

At Enterey, we operate on the basis that if we invest in helping people thrive, they’ll help us deliver the change we’re asking them to buy-in to. This people-first approach means that, rather than swooping in and implementing a serialization solution that no-one believes in, we are able to devise a plan that will actually work for your company. This is what separates us from our competition, and the reason our clients choose to work with us on a long-term basis.

Once you understand this core aspect of the consultancy, you will have insight into whether or not they will work well as part of your team.


If you’re looking to hire a consultancy to help you a) achieve serialization within the mandated deadlines and b) define a strategy that looks beyond compliance in order to drive value from your new capabilities, get then in touch with me, Mike (CEO) on mike.ferletic@enterey.com or call me directly on 949 336 5200 (x104).


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