The Drug Supply Chain and Security Act (DSCSA) has ushered in a number of regulatory mandates that have had and will continue to have a profound impact on the pharmaceutical industry — not the least of which is the next directive looming over manufacturers: Serialization by November, 2017. Serialization creates unprecedented challenges for pharmaceutical companies as it relates to scalability, technology infrastructure and operational protocols. For this reason, and the lengthy, staged-approach successful serialization demands, it’s critical manufacturers partner with an experienced ally to consult, strategize and support serialization efforts.

Are you prepared for DSCSA? Learn more about the upcoming challenges for manufacturers and how to combat them.

For more than two decades ICS has served its clients as a valued consultant in stringent regulatory matters. Our system architecture is 100 percent compliant with DSCSA phase I lot-level requirements and we have been running serialization pilots with current clients since the first quarter of 2016. This deep experience and knowledge has helped to shape a suite of scalable solutions designed to meet a variety of serialization needs, including:

  • Data storage/repository services: ICS offers state-of-the-art data storage/repository along with reporting for easy retrieval. We also support a transaction record retention policy of 7+ years (DSCSA requires 6 years).
  • Serial number generation and verification: Through a secure, verification portal, ICS offers clients 24/7 access to status, enabling a clear understanding of where product sits within the supply chain.
  • Relabeling/rekitting services: Advanced technologies and an FDA-validated license for relabeling and rekitting ensures clients a full-range DSCSA-compliant solutions.
  • Third-party integration: ICS has the ability to integrate with a wide variety of trading partners supporting track-and-trace efforts.

Are you working with a 3PL to handle your serialization needs? If not, let the ICS serialization team bring you up to speed — fast.

Learn more about what manufacturers’ 2017 serialization deadlines mean to 2023 compliance.