Customs Brokerage Tips for CRO/CMO Lab Shipments
General
Key takeaways
CROs and CMOs must comply with U.S. customs regulations when importing or exporting regulated shipments.
Permits and documentation are essential to prevent delays, fines, or product loss.
Common pitfalls include misclassification, incomplete forms, and failure to meet biosafety or accessibility standards.
Mercury provides specialized support to simplify customs brokerage for regulated life sciences shipments.
Understanding the CRO and CMO Shipping Landscape
Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are critical partners in drug development and production. These companies frequently ship investigational drugs, human specimens, reagents, and clinical trial materials across borders.
These shipments often contain sensitive or regulated content, such as biological samples, pharmaceutical products, or lab equipment. Delays or mistakes in customs clearance can disrupt research timelines, impact trial outcomes, or result in compliance violations.
Customs brokerage is the process of clearing goods through customs barriers for importers and exporters. For CROs and CMOs, navigating customs requirements can be especially complex due to the nature of the materials involved.
Essential Permits for Life Sciences Shipments
Before a shipment reaches the border, it's essential to confirm whether permits are required. Biological substances may fall under the jurisdiction of agencies such as the CDC, USDA APHIS, FDA, or EPA. Each agency has its own regulations and permitting systems.
For example:
The CDC requires an import permit for potentially infectious human-derived materials.
The USDA APHIS regulates animal-derived substances and may require additional screening.
The FDA oversees drug and device imports, particularly investigational products or those not yet approved for sale.
Each agency evaluates risk based on product content, origin, destination, and intended use. CROs and CMOs must ensure the right permits are obtained and valid before shipment.
Key Documents for Clearance
Successful customs clearance hinges on submitting complete and accurate documentation. The key forms typically include:
Commercial Invoice: Lists contents, declared value, and sender/receiver details.
Packing List: Outlines quantity, weight, and arrangement of goods.
Bill of Lading or Air Waybill: Describes the shipment and mode of transport.
Import Permits: Issued by agencies such as CDC or APHIS for regulated goods.
Importer Certification Statement: Required for specific human samples.
Section 508-Compliant Files: Digital documentation must meet federal accessibility standards.
Incomplete or inconsistent documentation is one of the most common causes of customs delays.
Common Pitfalls CROs and CMOs Should Avoid
Customs brokerage for clinical trial logistics involves several risks. Recognizing common pitfalls can help CROs and CMOs avoid costly setbacks.
Incorrect Classification: Using the wrong Harmonized Tariff Schedule (HTS) code can lead to inaccurate duties or regulatory missteps.
Missing or Expired Permits: Submitting expired or inapplicable permits is a red flag for customs authorities.
Lack of 508 Accessibility: Digital files submitted to federal agencies must be readable by screen readers.
Improper Labeling: Packages must clearly show biohazard symbols, UN codes, and temperature instructions.
Ignoring Partner Country Rules: Exporting countries may have additional regulations not reflected in U.S. customs protocols.
Each pitfall delays delivery, creates additional costs, or potentially invalidates the shipment.
Understanding the Role of the Customs Broker
A licensed customs broker serves as a liaison between the CRO/CMO and customs authorities. Brokers prepare documentation, verify permit accuracy, calculate duties, and facilitate clearance.
While many logistics providers offer general customs services, CRO and CMO shipments require deep expertise in regulatory compliance. Brokers must stay current on federal regulations, permit updates, and agency guidelines.
A qualified customs broker reduces the risk of shipment rejections, penalties, or lab operation disruptions. Choosing the right partner can make or break your trial timeline.
How Mercury Supports CROs and CMOs
Mercury specializes in supporting the life sciences industry with regulatory-compliant shipping services. Their team works closely with CROs, CMOs, and laboratories to ensure seamless customs clearance.
Regulatory Expertise: Mercury understands the regulatory obligations specific to pharmaceuticals, medical devices, diagnostics, and biological specimens. They assist with securing CDC, APHIS, and FDA permits.
Documentation Support: Mercury prepares and audits all documents, including invoices, packing lists, and shipping manifests. Their digital files comply with Section 508 standards, ensuring fast processing by federal agencies.
Customs Broker Partnership: Mercury partners with licensed customs brokers experienced in high-complexity shipments. These brokers understand the needs of clinical trials and time-sensitive deliveries.
Real-Time Visibility and Risk Management: Mercury offers real-time tracking and alerts. If a shipment encounters issues at customs, Mercury’s team takes immediate action to resolve it.
Temperature-Controlled Packaging and Compliance: Their validated packaging meets IATA and CDC standards, protecting sensitive materials like reagents, tissue samples, and controlled substances.
Integrated Project Support: Mercury provides dedicated account managers and 24/7 support. Their integrated approach helps CROs and CMOs focus on clinical results rather than logistics.
Best Practices for CRO/CMO Customs Success
Start permit applications early to account for agency review times.
Ensure HTS codes match the shipment's content and intended use.
Prepare Section 508-compliant digital documents.
Label all packages clearly, including hazard classifications and temperature requirements.
Partner with experienced logistics providers that understand clinical operations.
Compliance starts with preparation. Avoiding missteps saves time and protects the integrity of your materials.
Avoid customs delays and regulatory issues by working with a trusted logistics partner. Mercury supports CROs and CMOs in navigating permits, forms, and customs clearance with precision. Contact Mercury today to keep your regulated shipments compliant, secure, and on time.
