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

Our Services

What We Do Best

We leverage our years of experience supporting internal compliance programs 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 export controls and sanctions as well as more general compliance risks for our clients. Our background enables us to design and implement processes and programs that work in practice for companies of all shapes and sizes.

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.

Export Control 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.  Having a fit-for-purpose compliance framework to mitigate export 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.

Economic Sanctions Regulations

Doing business at an international level introduces numerous challenges, not the least of which is compliance with economic sanctions regulations. Economic sanctions are imposed by regulatory bodies worldwide, frequently change, and may be applicable to a business in unexpected ways. We have expertise in determining the applicability, and impact, of U.S. sanctions regulations to non-U.S. companies and in designing, establishing, and running a sanctions compliance program to mitigate worldwide sanctions compliance risks of a large multinational biopharmaceutical company.

Whether your company is American and engaged in international trade so require a sanctions compliance program to meet the obligations as defined in OFAC’s Framework for Compliance Commitments, or is American or foreign and needs to understand generally global sanctions risks, or is interested in acquiring a company involved in international trade that may present a sanctions compliance risk, we can help.

Get In Touch

URBANEK COMPLIANCE CONSULTING

BECKY URBANEK

becky@urbanekconsulting.com

+1-302-722-5103