Clinical Trial Regulatory Compliance, Simplified
We Navigate the Regulatory Maze For You
From import licenses to shipment documentation, we handle the import and export paperwork, so your clinical trial stays on track. Avoid delays, misdeclarations, and administrative headaches. Every country, every shipment, every time.
Exporting Excellence. Enabling Breakthroughs.
The Regulatory Challenge
Running a clinical trial is complex enough. Navigating the maze of regulatory requirements shouldn’t add to your burden, but it often does. Each shipment of clinical trial supplies requires multiple permits, tailored to every commodity and destination.
Administrative work piles up, commercial documentation can overwhelm teams, and a single misstep can delay customs clearance or even jeopardize your entire trial timeline. There’s no need to take that sort of risk when patient outcomes are on the line, and the success of your clinical trial relies on efficient, effective regulatory compliance.
Audit Risk
Clinical trial shipments are subject to strict audits by authorities and sponsors. Incomplete or inaccurate documentation can trigger inspections and compliance questions.
Regulatory Risk
Every shipment must comply with complex, country-specific import regulations. Mistakes or missing permits can delay trials and create compliance violations.
Financial Risk
Delays, fines, or rejected shipments can result in significant financial loss for sponsors and CROs. Efficient compliance minimizes unnecessary costs and avoids expensive corrections.
Legal Risk
Non-compliance with import/export laws can lead to legal penalties or liability issues. All shipments must meet local and international regulations to protect your trial and your organization.
The most effective clinical trial operators outsource these risks to a specialist.
Our Regulatory Compliance Solution
Leverage our compliance expertise for your peace of mind.
TecEx Medical makes regulatory compliance seamless. We handle the details, manage the paperwork, and keep your shipments moving, so you can focus on running your trial.
Here’s what you can expect:
Attention to Detail
Every license, document, and shipment is triple-checked thoroughly by our team of experts.
Dedicated Account Manager
A single point of contact ensures continuity and accountability
Global Scope & Experience
We’ve worked with 99% of vendors, and we align them efficiently for smooth approvals.
Established Relationships
Our established networks reduce delays and help to mitigate unforeseen challenges.
Real-Time Shipment Tracking
Access dashboards and customised reports to monitor shipments and track import license quantities and statuses.
World-Class Team
Our team is on a mission to provide the best service in the industry, combined with highly innovative and strategic solutions that are fit for purpose.
Our global customs expertise has reduced import license processing times by 46%.
How Does It Work?
Discovery Call
We begin with a focused consultation to understand your study geography, timelines, and regulatory profile — so we can understand what you’re trying to achieve.
Tailored Proposal
Based on our deep experience across the globe, we’ll deliver a structured import solution aligned to your trial needs, budget, and compliance obligations.
Regulatory & Document Review
Our specialists then conduct a thorough assessment of your documentation, product classification, and country-specific requirements to ensure nothing slips through the cracks.
Import Setup & Coordination
We manage all necessary permits, licenses, and customs paperwork — ensuring that your shipment is fully compliant before it even leaves your warehouse.
Customs Clearance & Delivery
Acting as your legal IOR, we oversee end-to-end clearance and ensure timely, compliant delivery to your clinical site or local warehouse.
Ongoing Support & Visibility
Stay fully informed with real-time tracking through our online portal and a dedicated point of contact who knows your study inside and out.
Simply put, TecEx Medical is your one-stop shop for all clinical trial logistics:
Success Stories
Expedited Import Licensing in Bosnia
For a clinical trial targeting severe Ulcerative Colitis, TecEx Medical was tasked with coordinating urgent IMP shipments into Bosnia, a country with particularly rigid, lot-specific import license requirements. A last-minute error by the CDMO depleted the batch for which an import license had already been secured. Normally, obtaining a new license in Bosnia takes approximately one month, but the patient dosing window was only one week away.
TecEx Medical’s Intervention
Working closely with the Sponsor, CRO, CDMO, and in-country regulatory authorities, TecEx successfully secured an expedited import license approval in under one week. This marked the first fast-tracked license granted by Bosnia’s health authority, a significant milestone given the agency’s strict and inflexible procedures.
Outcome
- The patient was dosed on time.
- Trial timeline remained intact.
- Full regulatory compliance was ensured throughout the process.
- Demonstrated the value of a centralized, expert IOR in navigating complex regulatory environments while prioritizing patient welfare.
Navigating Certification Requirements in Mexico
A vendor supplying clinical trial technology devices was struggling to import their products into Mexico due to NOM certification requirements, putting a large sponsor’s study at risk.
TecEx Medical’s Intervention
TecEx Medical guided the vendor through the full certification application and approval process, ensuring all documentation and regulatory obligations were met efficiently.
Outcome
- Devices were imported without restriction.
- Regulatory compliance was fully maintained.
- The vendor gained a competitive advantage, securing new opportunities with sponsors that competitors could not fulfill.
Unlocking Clinical Trial Shipments in Canada
A sponsor was unable to initiate shipments of investigational medicinal products (IMPs) into Canada following updates to the Canadian Border Services Agency’s new CARM (Assessment and Revenue Management) platform. The regulatory changes effectively blocked imports, halting progress on a clinical trial.
TecEx Medical’s Intervention
We stepped in to navigate the updated import framework, managing the complex regulatory requirements and liaising with Canadian authorities. Our team ensured all permits and documentation were accurately completed, restoring the flow of shipments.
Outcome
- Shipments were successfully cleared into Canada.
- Trial timelines resumed without further delay.
- Full regulatory compliance was maintained, avoiding any risk of customs penalties or trial disruption.
These stories are just a few examples of where TecEx Medical’s global networks and hyper-local expertise have proved invaluable for clinical trials across the world. We service 90+ countries including, but not limited to:
EU, USA, UK, China, Canada, Australia, Republic of Korea, Japan, Taiwan, Brazil, Argentina, Israel, Turkey, Mexico, Chile, India, Switzerland, South Africa, Thailand, Malaysia, Singapore, New Zealand, Norway, Columbia, Serbia, Georgia, Croatia, Philippines, Vietnam, Saudi Arabia
Start your Compliance Journey with TecEx Medical Today
Don’t let regulatory complexity slow down your trial. Reduce risk, save time, and ensure every shipment is compliant – without the administrative burden.
Surely that’s worth a conversation?