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we offer services to help companies become compliant - and more.



Companies are feeling the urgency to get serialization in place - we have outlined here some of our offerings - if you have other needs not listed, we would be happy to discuss how we can help you achieve your goals.





serialization strategy and assessment



The Drug Supply Chain Security Act (DSCSA) deadline for Manufacturers to ship prescription products with unit-level serialization is less than two (2) years away. The LinkLab

consultants can review your path to compliance, identify gaps based on our experience, and provide a roadmap to make sure you meet the expectations of the law.

Our assessment will measure your project against best practices for project management, resource engagement, governance, and vendor selection. We will ensure that you can leverage our previous DSCSA successes to be compliant before the November 2017 deadline.



serialization project management



The LinkLab can leverage our previous DSCSA project management experience to deliver updated business processes, new packaging and distribution infrastructure/hardware, and tools to ensure that your company is compliant.

We have experience with driving integrated teams (Artworks, Packaging, Distribution, Commercial, Quality, and IT) to help you achieve DSCSA compliance before the FDA's deadline.



identification of business value



There is real business value in unit-level serialization beyond just compliance. And we can help you find it.

Unit-level serialization can change how companies interact with patients and healthcare providers and there will be
quantifiable business benefits from these interactions.

By 2020 p
atients may be able to access services through smartphones including verifying the authenticity of their prescriptions. They may also be able to utilize electronic co-pay cards and easily report adverse events.

Healthcare providers may be able to authenticate medicines at the point of administration, view their product’s path through the supply chain, and manage inventory.


Have you thought of what business value serialization can provide? Let us help you figure it out.



vendor assessment



We have worked with many serialization packaging vendors and DSCSA middlemen. We can help you find the right combination of support.

Serialization vendors will become the critical path to compliance. To avoid delays in equipment delivery or challenges with support,
your company needs to make sound vendor choices for serialization.



320 ALABAMA STREET, SUITE #3, SAN FRANCISCO, CA 94110
info@thelinklab.com