Going forward, regulatory preparedness will determine the viability of your business.

Dozens of countries have passed mandates to safeguard prescription drugs traveling through the supply chain, with each law specifying the requirements of different supply chain segments.  As a contract manufacturer or packager, your company does not have legal responsibilities under the regulations, but the impact of compliance will nonetheless change the face of your business.

As the deadlines for U.S. DSCSA, EU FMD, and other major markets approach, your pharmaceutical customers must insure that all their products are serialized, including those handled by contract partners. That requires establishing connections with each of your pharma partners, a significant technology hurdle. Your ability to retain customers hinges on how proactive you are in preparing for the deadlines, addressing many new challenges along the way, including:

  • Gathering the unique requirements of each customer;
  • Identifying a means of exchanging compliance data;
  • Securing a place on each customers’ onboarding schedule;
  • Establishing a connection with all your pharma brands;
  • Identifying, ordering, and implementing new hardware;
  • Determining support for aggregation on all some, or no lines;   
  • Choosing a financial model for allocating serialization expenses;
  • Selecting a trusted advisor and solution partner for the serialization process. 

The next few years will introduce risk for your company, but also opportunity:  pharma brands have indicated that they will reallocate their business if partners are not ready in time, but early-moving CMOs and CPOs can use serialization readiness as a competitive advantage to acquire new business.  Getting started early, and choosing a technology that streamlines the monumental task of connecting to many customers, are both key to the ongoing success of your business.

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