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By the time the Drug Supply Chain Security Act goes into full effect this coming November, pharmaceutical trading partners will be navigating a complex, high-stakes regulatory landscape that requires meticulous compliance.
By the time the Drug Supply Chain Security Act goes into full effect this coming November, pharmaceutical trading partners will be navigating a complex, high-stakes regulatory landscape that requires meticulous compliance. Existing business challenges can be exacerbated by exceptions, as unforeseen errors can create new delays; new processes and time sinks will be created just to keep product moving at prior levels.
In short, keeping up with evolving regulations can be challenging, even for seasoned industry experts. As companies grapple with the demands of DSCSA, outsourcing compliance tasks to experts can offer significant time savings and provide a valuable "translator" for complex legislation.
The regulatory landscape is completing a 10-year transformation, and many organizations are already having trouble connecting the “new normal” of DSCSA to their previous operating SOPs; this issue could even be exacerbated by regulations and changes that emerge after this year. Staying abreast of these changes and their implications can be overwhelming, particularly for supply chain operations already dealing with multiple responsibilities.
Outsourcing DSCSA compliance to professionals who specialize in regulatory affairs ensures that businesses have dedicated experts tracking and interpreting regulatory updates. In addition to navigating the complex framework of DSCSA, this reduces the risk of overlooking critical changes and helps companies adapt their compliance strategies proactively.
Experts like those at Proactive Resource Group act as knowledgeable "translators" who can interpret intricate legislation and ensure that compliance efforts are aligned with the latest regulations. By leveraging their expertise, companies can optimize their time and resources, allowing staff to focus on core competencies while leaving compliance matters to professionals.
Outsourcing DSCSA compliance does not mean relinquishing control; instead, it enhances it through transparent collaboration. Working with Proactive Resource Group guarantees clear, open, and consistent communication on compliance activities, enabling customers to maintain an active understanding without having to micromanage decisionmaking. By fostering a collaborative relationship, PRG empowers businesses to hold control over their compliance efforts while benefiting from PRG’s expertise and support.
Additionally, outsourcing of DSCSA compliance tasks provides an additional layer of protection against operational disruptions. PRG’s compliance professionals are well-versed in exceptions management, ensuring that any errors or discrepancies in EPCIS files are promptly found and resolved, preventing supply chain disruptions and maintaining smooth product flow to your customers and their patients. By outsourcing these critical tasks, companies can mitigate risks associated with non-compliance, protect their reputation, and maintain uninterrupted operations.
By leveraging the expertise of PRG’s compliance team, you can stay in control of your DSCSA compliance position without making big investments of time and money. Learn more about working with PRG today.