Importation Management Services
Navigating the Complexities of Importing Investigational Material
Our in-house import and logistics specialists are experts in moving investigational material worldwide. We provide importation management services, including acting as the Importer of Record (IOR) and the Ultimate Consignee, ensuring that you have the clinical supplies you need, whenever you need them, anywhere in the world—freeing you to focus on the success of your clinical trial.
CalCog’s Importation Management Services
Our experienced team has been providing import guidance and services for nearly three decades, so we understand the complexities of quickly moving investigational material around the world.
We expertly handle the details and logistics of shipping investigational material, including:
- Documentation creation and review
- Customs clearance
- Duties and taxes
- Transportation charges
Turning to CalCog for importation management services allows you to focus your resources on core value-delivering activities, avoid clinical trial delays caused by customs clearance challenges, and adhere to all compliance requirements.
Importation Services
To allow for the efficient importation of drug product into different geographies around the world, CalCog provides comprehensive importation services.
Document Generation
Generation of all your shipping documents and liaising with your importer to ensure a smooth transit.
- Standard documents (invoice, packing lists)
- Country Specific documents (USDA statement, end user letter)
- Trade documents (certificate of origin, etc.)
Broker Communication and Customs Clearance
Access to the world’s largest customs brokerage providers to ensure compliance with complex individual country requirements. These services include:
- Wide-ranging knowledge to support the clearance of time-critical shipments
- A focus on healthcare compliance to meet all regulations and minimize risk
Duty & Tax Management
Expertise in Harmonized Tariff Schedule (HTS) codes, helping ensure the correct payment of duties and taxes.
Importer of Record (IOR)/Ultimate Consignee
IOR services in the United States and the United Kingdom and through our partner depots for the EU and many other countries globally. These capabilities allow us to:
- Take legal responsibility for the import
- Ensure that the import is completed in line with all current regulations
- Ensure the correct payment of duties and taxes
- Provide guidance to the shipper and grant approval to ship
Logistics Consultation
Specialty advisory services to reduce the complexity of global logistics. These services include:
- Dangerous goods classification advice
- Packaging options (temperature controlled, re-usable, etc.)
- Country requirements for specific regions, including depot availability and usage
- Courier selection (integrator, specialist, freight forwarder, etc.)
Frequently Asked Questions
What is an Importer of Record?
An Importer of Record (IOR) is responsible for the legal and compliance details of importing clinical materials, including Investigational Medicinal Products (IMPs), and for ensuring clinical trial supply chain integrity.
A knowledgeable and experienced IOR achieves successful importation through strategic planning and established processes, ensuring control, compliance, and supply chain visibility.
What is an Ultimate Consignee?
A US-based Ultimate Consignee is required if a foreign entity is acting as the IOR for IMPs being imported into the United States of America. The Ultimate Consignee is responsible for the legal and compliance details of importing clinical materials, including IMPs.
29
Years Supporting Clinical Programs
25,000+
Global Shipments Annually
150
Countries Importation Managed
6
Continents with Active Programs
Need Help Managing the Importation of IMP and Ancillary Materials for Your Clinical Trial?
Our in-house import and logistics specialists are experts in moving investigational material around the world—navigating the ever-changing global regulations and guidelines.