More case studies
Challenge
A leading pharmaceutical company reached out to CSI to source expensive comparators for their study running in China.
Navigating the meticulous regulatory landscape for exporting medicinal goods into China was a challenge, requiring provision of an extensive list of documentation, including a Certificate of Origin (COO) and the First Leg Document which encompasses a Certificate of Conformity (CofC), Certificate of Analysis (COA), commercial invoice, packing list, airway bill, drug product chain of custody, and shipping invoice.
There was also added logistical complexity involved in coordinating multiple shipments of sensitive, temperature-controlled medicines across different countries and time zones.
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Result
The success of the trial depended on CSI’s timely import and export of the comparators while maintaining compliance with Chinese regulations.
CSI’s collaboration with a trusted global logistics partner resulted in a streamlined transport and tracking process, minimising delays and ensuring the integrity of the product during transit.
This case study highlights the importance of regulatory expertise, logistical efficiency and meticulous documentation management and well-established relationships with pharmaceutical manufacturers for the success of global clinical trials.
Solution
Our dedicated team of project managers and Quality department leveraged their comprehensive understanding of import/export requirements and strong relationship with the manufacturer to directly obtain the CoO and compile all the necessary documentation for inclusion with the shipments.
Once the product had cleared customs in China, CSI established close communication channels with our global logistics partner, who has a strong presence in the country and is experienced in handling pharmaceutical shipments, including temperature-sensitive clinical trial supplies. This ensured facilitate real-time updates on shipment status, which could in turn be relayed to the client.
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Case Study
CSI’s seamless comparator export to China
Export of expensive comparators from Europe to China with first leg documents and streamlined approach
Challenge
A leading pharmaceutical company reached out to CSI to source expensive comparators for their study running in China.
Result
CSI obtained all necessary approvals and licences, ensuring compliance with Chinese regulations and the smooth import of medicines into China.
Solution
CSI Successfully managed to obtain the First Leg Documents thanks to our longstanding relationship with manufacturer and this significantly reduced the risk of customs clearance issues, enabling timely entry of clinical trial supplies into China.
Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements
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