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How the Pharma C-Suite Can Stop Worrying and Learn to Love Serialization

By February 10, 2016March 16th, 2021DSCSA, Serialization

Executives worry a lot, especially in our industry. But even more so in recent years, given the rapid changes in pharma and the looming compliance requirements in the Drug Supply Chain Security Act (DSCSA). The DSCSA’s serialization deadlines have implications that run deep into pharmaceutical manufacturing, distribution, and packaging businesses – so yes, there’s a lot to think about and plan for.

I know because I’m deeply involved in the industry, developing strategies and solutions for those same businesses. And in doing so, I talk to pharma executives every day – people with business-critical decisions to make about complicated regulatory, technological, and organizational challenges across their organizations. So what are executives most concerned about? Based on my conversations and research, here are the…

Top 10 Regulatory Concerns that are Keeping Executives Up at Night

  1. Serialization deadlines: Will we be compliant by 2017 in the U.S, and by 2018 in Europe?
  2. Global compliance: Will we be compliant in China, Korea, Turkey, Argentina, Brazil, Saudi Arabia, and other countries?
  3. Vendors: Are my CMOs and third-party logistics providers compliant?
  4. Unforeseen ramifications: How is serialization really impacting my company and employees?
  5. Penalties: What are the real penalties for non-compliance from the FDA and our trading partners?
  6. Localization: How will serialization impact our headquarters and satellite offices?
  7. In-house skills: Are my people knowledgeable enough to work on serialization? Can they handle that role in addition to their regular jobs, or should they do serialization full time?
  8. Global coordination: Do I create one team across all geographies, or local country teams? How will they communicate with the rest of the organization?
  9. Technology: Can our legacy systems manage the serialization data requirements?
  10. Security: Will our serialization process create security vulnerabilities?

While you executives are right to be thinking about all of these issues, worry doesn’t need to be part of your DSCSA and serialization process.

LSPediA: Pharmaceutical Services for Better Business Outcomes

Here are some other things I’ve heard from pharma executives:

“We were able to work with LSPediA to successfully complete our serialization and DQSA project for the 2015 launch. Currently we are working with LSPediA on 2017 serialization requirements and ERP which is absolutely critical to our business.”

– Marc Bonner, Senior Director of Operations, Mayne Pharma

“LSPediA makes life a lot easier for me…. Working with LSPediA is like having a tour guide that goes a step above, they are a partner and they’re in there working with you.”
Ed Patel, Director Metrics Contract Services, Mayne Pharma

We offer solutions for every part of your business – including serialization services, regulatory compliance, Technology services, and enterprise resource planning (ERP). Plus, our new LSPediA Serialization Toolkit will help ensure every stakeholder in every line of your business is equipped, trained, and prepared to implement a serialization process within your company.

Let’s Get Started Today

What are your worries? Whether they made our list or not, I’d like to hear about them. Contact us anytime and I’ll tell you how LSPediA can ensure your business is compliant, competitive, and positioned for growth – according to your schedule and budget needs – and ensure that you have peace of mind.