+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.

Compliance Program Frameworks

The expectations from regulatory bodies continue to increase, as evidenced by the evolution of anti-bribery, anti-corruption regulations such as the FCPA and UK Bribery Act, regulations in the financial space such as SOX, and international trade regulations such as those by OFAC; these expectations and requirements oftentimes extend beyond what would seemingly be country borders. Similarly, there is increased awareness and expectations from shareholders that companies have a “doing business the right way” approach to support long-term sustainability goals and protect its reputation. A well-designed compliance framework will help pragmatically meet these expectations.

We assist companies to identify compliance risk and design a risk-informed framework to prevent, detect, and respond to compliance matters. We have experience in design and execution of compliance program frameworks for several distinct regulatory and risk areas and have supported compliance for many risk areas in a geographically diverse, highly regulated multinational company.

Whether your company is looking for an overarching compliance program framework or a specific program to meet requirements in one regulatory or risk space, we can help.