Natco Pharma USA – Case Study

Operational Efficiency & Compliance

How VariTec Helped Unichem Pharmaceuticals Achieve 100% DSCSA Compliance and Reclaim Critical Time?

What specific DSCSA or serialization challenge(s) were you facing prior to our engagement?

Our company was originally working with our 3PL warehouse, which, early on, had offered DSCSA support, simply worded in a bullet point and a short addendum to our contract. At the time, and for 2-3 years following, we did not realize the full complexity involved with impending DSCSA compliance. As the DSCSA timeline advanced quickly towards the various traceability and interoperability compliance dates, we began to review what we were signed up for, which seemed very basic, and the lukewarm activity that we had seen to-date. We began to realize that we needed more focused attention and a way of auto-piloting our program, if possible, without losing sleep at night. It was time to engage a more experienced team to meet our needs.

How did our solution and support help address your compliance or operational goals?

Once we signed up with the VariTec team, we were delighted to see the team immediately start outlining processes for setting up our site and product master data, templating a customer master data and progress tracking list, liaising and working closely with our 3PL DSCSA contacts, and assigning highly knowledgeable key technical contacts to work with. I cannot underscore how impressed we have been with the technical consultants and their follow-up.

What measurable improvements or efficiencies have you seen as a result?

I’m not sure how to measure the near absence of DSCSA compliance stress, but it’s there and it is a relief! What IS measurable, at least in daily perception, is the huge reduction in customer and supplier Exception and support e-mails. The response time when reaching out to the team is impressive as well.

What aspects of working with our team stood out—whether technically, strategically, or relationally?

The VariTec team worked diligently in the background, and it didn’t seem to matter how many wrenches were coming at them. Each issue seemed to be calmly addressed, especially considering that some of the support requests were coming from highly- demanding customers or group organizations. There was never any loss of patience, regardless of the flurry of activity. That really stood out in our opinion. It’s also impressive how the team worked seamlessly with the Support team from our 3PL, as if they were all on the same team.

Would you recommend our services to other pharmaceutical manufacturers or supply chain partners? Why?

I would certainly recommend VariTec to other trading partners, and I know I speak for my management colleagues as well. The VariTec team is very attentive and prioritizes very well by getting to know the entities it is trying to support in the DSCSA- relevant Supply Chain. VariTec seems to be very well-connected with all of the major entities out there, which was very helpful in the onboarding processes. I felt that those very same entities knew they were dealing with a very knowledgeable group, and, in some cases, appeared to be further educated in the process!

client: NATCO Pharma, USA

David McClure
Director, Supply Chain & Logistics

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