Why Regulatory Expertise Is Critical to the Healthcare Supply Chain

Moving a vial of medicine or a bottle of pills from point A to point B is a lot different than transporting virtually any other type of product. Not only are pharmaceutical goods and biological materials typically highly sensitive, requiring strict packaging and transportation conditions, but they’re also subject to a range of complex regional and local regulations. This makes it essential for shippers to have regulatory expertise on their side in order to prevent delays, mitigate the risk of noncompliance, and keep the healthcare supply chain moving smoothly.

The high price of import delays

Whether it’s a clinical trial transporting investigational drugs to the testing site or a pharmaceutical manufacturer sending life-saving medicines to pharmacies and hospitals, clearing customs in a timely fashion is critical to the success of any life sciences or healthcare supply chain.

Even the smallest delay can have huge consequences. Time- and temperature-controlled drugs can deteriorate or expire while sitting at the border, resulting in costly waste and, potentially, risk to the patient. Procedures can be postponed because vital drugs and equipment didn’t arrive in time. Freight can wind up quarantined because the proper paperwork wasn’t filled out—and, in some cases, may even be destroyed.

Navigating the ever-changing landscape of global regulations

To avoid issues at the border, shippers need to have a clear idea in advance of what the customs process will look like for any given shipment, and what they need to do to expedite clearance. This can include paying appropriate duty fees at the right time, double-checking that products are classified correctly (particularly dangerous and controlled substances), and ensuring documentation is properly prepared and included with the shipment.

Of course, developing an effective and efficient customs clearance strategy is only possible if shippers have a firm understanding of global regulations. This is easier said than done: customs requirements can be incredibly complex and confusing, and can vary dramatically from one region to the next. And since they’re always changing, it’s necessary to constantly monitor changes and adjust the strategy accordingly.

As such, it’s often a better use of a shipper’s resources to work with a logistics provider with regulatory expertise already and stays on top of changing regulations, rather than tasking staff with figuring out what needs to be done. In an industry as heavily regulated as healthcare—and with so much at stake—there’s little room for mistakes, and it really is better to be safe than sorry.

Supporting the healthcare supply chain

At CTSI-Global, we combine decades of logistics experience with a deep and nuanced understanding of the healthcare and life sciences space. Having worked with some of the leading players in these industries, we understand just how challenging it can be to navigate global regulations—and what it takes to move pharmaceutical and biological products safely, efficiently, and compliantly. We stay on top of regulations so you don’t have to, helping to mitigate compliance risks and prevent detrimental delays.

Find the expert support you need to smooth out every regulatory kink. Partner with us today.

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