When it comes to certifications and licensures, there are a lot of government regulatory agencies involved with programs that serve unique functionalities, which leaves organizations to ask themselves, “What exactly do these programs solve?” and “How can I benefit?”
The following programs solve common supply chain pain points through risk reduction, time savings, cost optimization, and increased regulatory confidence, especially when managed by one provider to reduce the number of handoffs for a fast, efficient, and straightforward logistics process.
Dangerous Goods and Hazardous Materials
Through the International Air Transport Association (IATA) and its Dangerous Goods Regulations, SciSafe team members are certified to classify, mark, pack, label, and document dangerous shipments and hazardous materials in compliance with air transport regulations. Common “dangerous goods” can include dry ice, medical devices, and infectious substances, but the category overall refers to articles or substances that pose risks to health, safety, property, or the environment during air transport. Shipments that are not IATA-compliant can be refused by airlines and detained by regulators, causing delays.
With a similar goal of regulating safe shipments, the US Department of Transportation’s Pipeline and Hazardous Materials Safety Administration, or DOT PHMSA, is responsible for the transportation of energy and other hazardous materials. For unique handling requirements, the DOT PHMSA can grant “Special Permits.” SciSafe’s Special Permit allows the legal transportation of infectious biological materials in temperature-controlled powered equipment rather than in passive packaging, for example, patient samples in ultra-low temperature freezers without temperature excursions causing degradation and loss of viability.
Certified Cargo Screening Program (CCSP)
The CCSP, through the TSA, enables Certified Cargo Screening Facilities (CCSF) to screen cargo prior to its acceptance by an Indirect Air Carrier (IAC) or Aircraft Operator. CCSFs must adhere to stringent security requirements and permit onsite validations as well as periodic TSA inspections. While materials are onsite, the facilities screen cargo at the piece level and maintain integrity through chain of custody measures.
CCSPs offer the substantial benefit of having cargo move more quickly through the supply chain, plus cargo does not require additional screening once accepted by a CCSF and can avoid potentially invasive screenings. This minimizes delays in transportation, which, in addition to preventing production from stalling, can help further protect against the risk of temperature excursions when the transported materials are under strict temperature control.
Customs-Trade Partnership Against Terrorism
A program through the US Customs & Border Protection (CBP), organizations that join C-TPAT agree to work to protect the supply chain, identify security gaps, and implement security best practices. C-TPAT partners are considered low risk, making them less likely to be examined at US ports of entry.
C-TPAT benefits go beyond reduced likelihood of examination, as some additional advantages include reduced number of CBP examinations, front-of-the-line inspections, shorter wait times at the border, business resumption priority following a natural disaster, and much more. Overall, enrollment in C-TPAT allows organizations to work with the CBP to improve the security of the supply chain and ensure smoother, more direct import and export of shipments.
Transported Asset Protection Association (TAPA)
Formed with the goal of minimizing loss by preventing the theft of cargo, TAPA is a global coalition of manufacturers, shippers, logistics providers, and law enforcement. TAPA sets and audits security standards, such as Facility Security Requirements and Truck Security Requirements, for high-value goods to ensure security throughout the supply chain. Membership with TAPA also enables access to their Intelligence Service database of cargo loss incidents and locations to improve security protocols with up-to-date information.
Biologics, pharmaceuticals, and cell therapies can be targets for cargo theft. In addition to reducing theft, TAPA certification reduces the illegal diversion of goods and insurance risk and protects product and patient safety. As of 2026, SciSafe’s East Brunswick, NJ facility has been a TAPA FSR B certified site.
Foreign-Trade Zone
Importation and its associated costs continue to be a prolific topic, especially as pharmaceutical companies shift to a domestic approach in storing bulk active pharmaceutical ingredients for a more convenient local supply.
Certified Foreign-Trade Zones (FTZ), also referred to as Free-Trade Zones outside of the US, offer a unique opportunity to delay, or even eliminate, the payment of import duties, or even eliminate the payment if the goods are exported directly from the FTZ. FTZs are considered outside of US customs territory, so when an organization certifies a FTZ warehouse with CBP, companies do not have to pay import duties until products leave the FTZ into the US, or whichever country the FTZ is located in.
FTZ certification makes it simple to keep raw materials nearby to prevent delays and improve overall supply chain efficiency. Plus, companies are not responsible for import duties for these materials until they leave the FTZ warehouse.
Customs Bonded
Similar to FTZ facilities, a customs bonded warehouse is where materials are stored before import duties are paid. The difference lay in that bonded warehouses are under US CBP supervision for the securing of materials “which may be stored, manipulated, or undergo manufacturing operations without payment of duty for up to 5 years from the date of importation,” while they remain in the warehouse. Another contrast when comparing FTZs vs. customs bonded warehouses is that bonded facilities are liable for the goods upon entry until the materials are exported, destroyed under CBP supervision, withdrawn for supplies, or withdrawn for consumption in the US after duty payments.
Along with the advantages of keeping a local supply of materials and the delay of import duties, customs bonded warehouses are backed by CBP-authorized liability to ensure import regulation compliance and financial responsibility for imports.
Wholesale Distribution
In 2013, the Drug Quality Security Act (DQSA) was signed into law, in which Title II, the Drug Supply Chain Security Act (DSCSA), replaced previous systems for tracking, tracing, and verifying drugs at the federal level to combat counterfeits from entering the US supply chain. Under the DSCSA, the FDA required wholesale drug distributors and third-party logistics providers to be licensed and annually report licensure and other information to be authorized trading partners in the US. This strict quality control from the FDA ensures risk mitigation, transparency and traceability, and enhanced patient trust starting from the manufacturer and distributor level.
SciSafe considers itself to be among those that pursue safe, simple, and secure solutions, which is why our NJ facilities are FDA-licensed for Wholesale Distribution. Further servicing manufacturers, SciSafe can go beyond GMP-compliant storage and distribute pharmaceutical products to hospitals, clinics, pharmacies, and more.
Minimizing Delays in the Supply Chain
Life science supply chains can rely on a wide variety of stakeholders to source active pharmaceutical ingredients, manufacture materials, provide packaging, and more. With a large number of organizations involved in such a complex process, timing is crucial to prevent setbacks from building up and resulting in drug shortages.
SciSafe believes in offering comprehensive customer-first solutions, which is why we listen to our partners to expand service offerings for all-in-one support from end-to-end of the global supply chain. Discover our full list of current certifications and accreditations or contact us today!