+1-302-722-5103 BECKY@URBANEKCONSULTING.COM

Our Services

What We Do Best

We leverage our years of experience supporting internal compliance programs for trade and other risk areas for multinational biopharmaceutical companies at both the enterprise and local level. This experience enables us to develop customized approaches to mitigate specific compliance risks for both export controls and economic sanctions as well as more general compliance risks for our clients. We also perform maturity assessments of trade programs- incorporating compliance and other considerations- and develop roadmaps for improvement. Our background enables us to design and implement processes and programs that work in practice for companies of all shapes and sizes.

Trade Program Assessments

Moving goods internationally is not just about the logistics of getting them from point A to point B- it also involves many regulations governing import and export. When contemplating a new international route or an entirely new supply chain with international parties, it is imperative to consider aspects such as who the legal importer and exporter will be, who is accountable for shipping, and the regulations specific to your material for the countries of its export and import.

We assess your company’s trade program to determine its level of maturity for topics specific to your business and work with you to develop a roadmap to reach your desired level.  This will identify and mitigate the risks of products being stopped at the border, overpaying of tariffs or other duties, and levied fines or time-consuming queries or assessments by Customs agencies. Our experience with both large and small companies in the biopharma sector and scientific background make us uniquely qualified to support your life sciences business.

Whether your company is planning for future international trade or is experiencing challenges in its current business, we can help.

Export Controls & Economic Sanctions Regulations

Exporting facilitates business growth by making new markets accessible. There are many regulations governing the export of items- whether they be goods, software, or technology- outside of the U.S. and even the re-export of U.S.-manufactured items from one country to another.  Likewise, there are economic sanctions regulations that restrict international business. Having a fit-for-purpose compliance framework to mitigate export controls and sanctions compliance risks will streamline processes, keep goods moving smoothly and protect from regulatory issues.

Our scientific training and background in biopharmaceuticals affords us the ability to readily support clients in this sector while our experience in setting up programs from the bottom up enables us to support any company not well acquainted with exporting.

Whether your company is new to exporting and could benefit from a simple process or have been exporting for some time but lack a structured compliance program, we can help.

Import & Export Classifications

Proper product classification is the foundation of compliance with import and export regulations. Customs agencies around the world require that companies transporting goods across their country borders have correct product classifications. Regulatory non-compliance is not the only reason for focus on this area; there are operational reasons as well, as incorrect import classifications can lead to paying incorrect rates of duty (either too high or too low) and import delays due to Customs queries or incorrect/missing partner government agency requirements. 

Classification can be challenging, as detailed product knowledge and technical specifications are required alongside knowledge of the regulations. Trade compliance personnel will understand the regulations, technical personnel will understand the product details, but the combination of the two skillsets is oftentimes missing. This can be particularly true for the life science, agricultural and chemical industries. Our experience in biopharmaceutical R&D and educational background in organic chemistry give us the qualifications to bridge this gap.

Whether your company would like assistance with occasional or frequent product classifications or a review of prior classifications, we can help.