Global Cold Chain Logistics & Regulatory Compliance Support
End-to-End Logistics Regulatory Support
At CoolReach, our team members have more than 20 years of domain experience, providing logistics support for highly sensitive biopharmaceutical goods and clinical trial materials across the globe. This ensures that we have a very deep & holistic understanding of global regulations and we are also very agile in adapting to changing requirements at both regional and local levels.
Our approach is designed to meet the evolving needs of the clinical trial logistics sector while maintaining full compliance with international standards.
Before the shipment, we will coordinate with your operations team to develop a cold chain logistics strategy that takes into consideration your product profile as well as region-specific import requirements to ensure that all regulatory requirements are strictly adhered to.
To support you with the regulatory concerns for your shipments, we will provide you with:
Regulatory Compliance Expertise:
This includes assisting in meeting regulatory requirements, such as Good Distribution Practices (GDP), and country-specific regulations enforced by health authorities. We also support organisations in aligning their documentation processes with clinical trial supply expectations for regulatory clarity and consistency.
Documentation Management:
We can provide your team guidance on maintaining essentially accurate and up-to-date documentation. This includes records related to temperature monitoring, transportation conditions, and any deviations from the standard operating procedures. Accurate documentation is essential for successful customs clearance services, helping to streamline processes, avoid delays, and maintain compliance throughout your cold chain logistics operations.
Quality Management System Support:
We can help our biopharmaceutical clients establish protocols for risk assessment, deviation management, and continuous improvement. This can include conducting regular audits and providing guidance for addressing any non-conformities. This level of oversight is essential for companies managing temperature controlled logistics in multiple global markets.
Regulatory Updates and Guidance:
We keep you informed about any changes in regulatory requirements, including regular updates on relevant regulatory changes and offering guidance on how these changes may impact your company’s operations and compliance strategies. We tailor these insights specifically to the challenges faced in clinical trial logistics to support uninterrupted global distribution.
Temperature Monitoring and Reporting:
We provide detailed reports to clients demonstrating compliance with regulatory standards, an essential component of managing biopharmaceutical goods within a complex cold chain logistics network.
Shipment Customs
Clearance Support
We offer our biopharmaceutical & clinical research clients comprehensive Customs Clearance Support when transporting temperature-sensitive materials internationally.
Our customs clearance support services can help you with:
Customs Regulations
We help you navigate the complex regulatory landscape and ensure that all customs regulations and documentation requirements are met in the exporting and importing countries. Our team’s expertise in logistics regulatory compliance helps streamline complex shipments across multiple jurisdictions.
Import and Export Duties
Understanding and navigating the intricacies of import and export duties, tariffs, and taxes is essential. We provide you with guidance on the applicable duties and taxes, ensuring that you are compliant with all financial obligations associated with the customs clearance process. This is especially important for organisations managing high-value clinical trial supply shipments that demand timely border clearance.
Clear & Transparent Communication
Effective communication with relevant customs-related authorities is vital. We maintain open lines of communication and provide regular updates on the status of the customs clearance process, ensuring transparency and accountability throughout the transportation and clearance of your biopharmaceutical products. This level of communication is crucial for pharma logistics operations that rely on real-time coordination and border efficiency.
Product Serialization & Track-and-Trace Compliance
In line with regulations such as the EU Falsified Medicines Directive (FMD) or the US Drug Supply Chain Security Act (DSCSA), we support clients in maintaining serialization and track-and-trace data throughout the logistics lifecycle — a critical compliance factor in pharmaceutical supply chains.
Documentation Management
We support our clients’ teams with the extensive paperwork and documentation involved in customs clearance. As a trusted provider of customs clearance services, we ensure each stage of the process is managed with precision and regulatory compliance.
We ensure that all necessary documentation is prepared and submitted accurately and on time. This may include commercial invoices, packing lists, certificates of origin, import/export licenses, permits, and any other relevant documents.
Risk Management
Mitigating risks associated with customs clearance is crucial to ensuring the smooth and timely transportation of temperature-sensitive pharmaceuticals. We support you with risk management strategies to address any potential challenges that may arise during customs clearance, such as delays, seizures, or compliance issues. Our experience in managing clinical trial logistics enables us to anticipate and resolve clearance-related risks before they impact delivery timelines.
Permit & License Coordination
We support clients in acquiring special permits and licenses required for transporting controlled substances, investigational medicinal products (IMPs), biological samples, or dangerous goods.
Our team liaises with local regulatory authorities or with the relevant CMOs to ensure smooth application, renewal, and approval processes for these critical logistics components.
