TecEx Medical are the industry experts in importation project management for the clinical trials. We are your go-to IOR and customs compliance partner for importing clinical, medical device, and ancillary supplies.
The clinical trial industry remains one of the most challenging areas of global trade. Companies face customs compliance hurdles in this rapidly advancing market.
Complexities such as country-specific Ministry of Health (MoH) requirements, clinical trial notifications, tariffs, licensing requirements and global trade agreements, are some of the many challenges faced by those in the clinical trial sector.
As a result, clinical trial supply chain management has become the pillar of efficient cross-border distribution.
Stuck shipments of clinical and ancillary supplies, missed Site Initiation Visit (SIV) dates and unexpected tariffs are the worst-case scenario for those conducting global clinical trials.
Yet an estimated 85% of clinical trials experience delays. Regulatory, procedural compliance, and clinical supply chain issues are some of the most common reasons for clinical trial delays.
TecEx Medical’s complete trade compliance and clinical supply chain management solution safeguards your international studies.
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Navigate regulatory requirements across different countries with expert guidance tailored to each clinical trial import/export market, ensuring full compliance from day one. |
Avoid customs delays caused by licensing and documentation errors by streamlining clinical trial product documentation, import permits, and pre-approvals. |
Ensure traceability and compliance for investigational product through validated, secure clinical trial shipping solutions and audit-ready supply chain processes. |
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Accelerate customs clearance through accurate classification and tax handling using expert HS code assignments and support with tax exemptions for clinical trial supplies. |
Manage complex multi-party coordination across clinical trial stakeholders with centralized compliance support that bridges sponsors, depots, and investigator sites. |
Operate compliantly in countries where they cannot act as Importer of Record by leveraging our global IOR services for clinical research organizations. |
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Ensure correct labeling, packaging, and documentation for clinical trial use with proactive support aligned to regulatory requirements for investigational drugs and medical devices. |
Distribute medical devices, eCOA and all clinical & ancillary supplies globally, including emerging markets with full-service clinical trial logistics and import/export compliance. |
Safeguard the cold chain and time-sensitive products during transit by mitigating delays that may cause cold chain disruptions by working alongside your preferred GDP-compliant partners for pharmaceutical cold chain logistics. |
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Resolve customs compliance challenges during clinical trial shipments with access to global regulatory guidance and trusted Importer of Record capabilities. |
Access high-risk or restricted import markets with confidence through our extensive network of customs clearance solutions for clinical trials. |
Reduce delivery risks for investigational products through proactive compliance checks, minimized shipment holds, and faster turnaround times. |
Provide project support
or clinical trials by obtaining regulatory approvals, managing inventory, compliance risk mitigation, and shipping samples.
Navigate the regulatory requirements
for clinical trials and ensure they comply with all applicable regulations.
Increase trial efficiency
by streamlining business processes and reducing the risk of delays through a single point of contact.
Manage project efficiency
by ensuring complete regulatory import and export compliance in destinations around the world, including China, Mexico, America, and more.
Avoid costly penalties and delays
by efficiently filing customs clearance documents, paperwork, registrations, and paying duties and taxes on your behalf.
Provide cross-border expertise
by sourcing and managing regulatory requirements, licenses, and permits.
Manage and advise
on various pain points in the supply chain – from regulatory requirements and compliance risk management to time sensitivity and noncompliance penalties.
Handle administrative responsibilities
from the beginning of your trial through its completion. Our project management solution ensures a more compliant and efficient supply chain.
Streamline global deployments
by integrating supplier and service provider relationships across the supply chain.
Since cross-border clinical trials and import/export controls are so intricate, enlisting the help of a trade compliance expert can make your trial or clinical investigation quicker and more efficient. TecEx Medical provides a complete cross-border project management solution supporting your clinical trial in multiple destinations from inception to completion. Our value-added services also ensure safe and efficient delivery for your clinical trial.
We’re more than just a consignee; we act as your local and legal representative for importing medical commodities. This means we handle all the paperwork and import requirements for customs clearance so that you can focus on your trial.
We also help with the export of your clinical trial supplies, which includes exporting medical devices at the end of the clinical trial and facilitating biological sample shipments to central labs. We can support export license applications & filings wherever required.
We apply for all required permits and licenses to import medical commodities. This ensures that your clinical study complies with all origin and destination country compliance requirements.
From Clinical Trial Notifications to customs clearance, we manage everything, including customs documentation, regulatory submissions, import registrations, and the payment of duties and taxes. Whether you’re navigating European Union regulations, importing into an isolated country like Australia, or expanding globally, TecEx Medical ensures your clinical trial materials are delivered without delays, penalties, or compliance issues.
Find further information about how our project management solution enables clinical trial deployment.
Don’t let surprise tariffs stall your shipments. Tune in for global trade insights and real compliance fixes from TecEx experts.