Sentry BioPharma Services, Inc., a contract service organization, supports the life science industry by offering GMP temperature controlled storage, distribution, FDA compliant labeling and packaging services, and importation support utilizing Foreign Trade Zones (FTZs). As global trade volatility increases and new tariffs and taxes are imposed on pharmaceutical imports into the U.S., FTZs have become increasingly sought after for the flexibility and cost savings they allow. FTZs enable businesses to lock in tariff rates, store materials without immediately incurring duties, and hold products for global labeling and packaging while avoiding unnecessary tax exposure.

In this conversation with Contract Pharma, Alex Mitchell, Vice President, Operations, Sentry BioPharma Services Inc., discusses the growing use of FTZs by pharmaceutical companies. He highlights Sentry’s specialized services, such as GMP-compliant storage, labeling, packaging, and end-to-end GxP logistics, as well as its strategic locations that offer strong infrastructure and reduced natural disaster risks. He also emphasizes Sentry’s expertise in compliance, meticulous record-keeping, and consultative support to ensure secure, efficient global supply chain operations.

Contract Pharma: How has the current global political climate impacted utilization of FTZs for pharma companies?

Alex Mitchell: With the advent of additional or new taxes and tariffs on import of pharmaceutical materials into the USA, manufacturers and developers alike are evaluating their global supply chain networks. Sentry is seeing its clients request to use our FTZs to derisk the volatile trade and tariff environment. Primarily, we see clients employing our FTZs to lock in tariff rate(s), to park materials with an unknown destination country in a tax and tariff averse fashion, and to hold drug products for further global labeling and packaging. There has been a marked increase in FTZ interest since January of 2025 and all of Sentry’s U.S. facilities are 100% bonded FTZ spaces.

CP: What are the most requested services within an FTZ? And how does Sentry set itself apart in offering those services?

Mitchell: Sentry primarily offers GMP storage in ten different GMP temperature ranges, with the highest level of redundancy for innately sensitive and valuable clinical and commercial pharmaceutical materials. All our U.S. facilities allow us to label and package in the zone under batch record control, to aggregate for commercial launches and meter tax and tariff impacts to clients by only importing limited quantities of materials into the USA from the zone.

Sentry is often leveraged for our FTZ expertise and consultative services, pre-IND drug product imports, and our end-to-end GxP logistics to assure properly documented turnkey movement of high value materials from CDMOs into our zones. Sentry manages the import formalities, paperwork checks and seamless movements of materials from over 50 countries into our FTZs, all with a high touch white glove service.

CP: How is material treated differently in an FTZ? Are you still subject to U.S. Customs and Border Protection and necessary reporting requirements?

Mitchell: As a Foreign Trade Zone administrator, Sentry must provide regular value reporting, separate specialized tracking of import documents and statuses and is subject to regular audits by U.S. Customs and Border Protection (CBP). To this date, we maintain a spotless inspection record with CBP. To maintain our zone(s), Sentry must keep meticulous records while upholding the Sentry standard – all materials stored at our facilities (cGMP or not) are cGMP pharmaceutical compliant. All materials admitted to the FTZ are held under the applicable status, accompanied by the necessary documentation, not distributed domestically prior to CBP/FDA approval, and overall product value is reconciled and recorded for all movements into and out of our FTZs.

CP: Do Sentry’s specific sites make them prime geographical locations for FTZ(s)?

Mitchell: Sentry BioPharma Services’ two purpose-built U.S. facilities are strategically positioned at two geographically differing locations in Indiana, where five major interstate highways connect. The driving factors supporting this decision were proximity to international cargo airports and the strength of Midwest logistics infrastructure, to provide a risk-averse approach for handling and storing high value pharmaceutical materials. Sentry’s headquarters is in Indianapolis, IN and our second location is in Edinburgh, IN. This allows access to 75-85% of the U.S. population within a one-day truck drive, from either of our facilities.

Unlike FTZs located on either U.S. coast, Sentry is not subject to innate hurricane risk, flooding, wildfires, or earthquakes. We maintain hardened facilities to withstand high wind events and are often tapped by clients for immediate transfer of materials from other facilities on the eastern seaboard where severe weather is more commonly known to strike. All these factors and Sentry’s best-in-class facilities have driven our record of no product damaged or lost in over 20+ years of unwavering service.

CP: As an FTZ subject matter expert, what advice do you have for companies exploring utilization of FTZs?

Mitchell: Sentry has maintained its FTZs for many years and while our role is important, transit of materials under bond, accompanied by the appropriate paperwork, is just as critical. It is our experience that many freight forwarders and brokers profess that they can handle FTZ import and export movements, though they often overlook details that cause key compliance concerns.

Sentry leverages highly qualified GxP freight forwarders and brokers that are qualified and audited based on the standards set within our GxP Quality Management System. This is to ensure strict compliance with all facets of FTZ regulations and to protect products in transit. When Sentry is in control, we are able to provide a comprehensive, consultative, and customizable FTZ offering that includes GxP compliant inbound logistics, storage and handling, outbound shipments and distribution into over 50 countries. In an ever-changing world, Sentry works to provide stability and peace of mind to its clients, consultants, and partners whether their material is at rest or in transit.

CP: How does Sentry’s expertise provide an added layer of benefits beyond its world-class facilities?

Mitchell: The Sentry approach is to provide the highest level of project management, client care, and customer service within a compliant framework of services. Quite often, the Sentry team is leveraged to map out holistic GxP end-to-end logistics, storage, packaging and distribution solutions, based on a specific issue statement.

Sentry’s extensive experience, dedication, and strategy-oriented team is always prepared to step back and evaluate each unique supply chain, to offer appropriate advice and identify solutions which may not have been previously considered. Sentry’s mission from our inception has been to customize our service offerings to appropriately address the specific needs of each unique project, mitigate risk, and ensure the best possible outcomes. We continue to supply this level of service to our clients, and our Foreign Trade Zones are a key tool we use to assist the pharma industry in this endeavor.