Our ServicesWhat We Do Best
We bridge the gap between science and compliance.
We capitalize on our chemical education and experience in biopharmaceutical R&D for a large multinational corporation to understand the technical details of our customers’ business, products, and research activities. We use this knowledge to analyze, design, and implement practical compliance programs for numerous regulatory areas, including trade compliance.
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 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., the re-export of U.S.-manufactured items from one country to another, and even the sharing of controlled technology with non-U.S. citizens within the United States. There are also restrictions on sharing certain items or technology with restricted persons, countries, or for restricted purposes.
Life science and biopharmaceutical companies routinely use materials that are controlled for export. They may also do R&D with these controlled materials, leading to the formation of controlled technology used to manufacture or use these goods. We use our experience to identify controlled materials and technology, determine their Export Control Classification Numbers (ECCNs), and develop practical ways to stay compliant with the export of goods and the sharing and storage of controlled technology that work for your business.
Whether you would like the analysis of a particular material or the review of a research program or group of goods, we can help.
Chemical and life science companies operate in a highly regulated, complex environment, with trade regulations being one aspect in this complexity. In addition to classifications for import and export, there are also requirements set by partner government agencies related to the specific product being imported. For companies in this space, these requirements may be set by health authorities such as the FDA, and authorities related to agriculture, wildlife, and plants such as the United States Department of Agriculture (USDA) or Fish and Wildlife Service (FWS).
Being unaware of the requirements can lead to import delays, and valuable time wasted responding to queries from the customs agency. For time- or temperature-sensitive products, this delay can be catastrophic to your materials. We work with our customers and their technical experts, third-party partners, and Customs Broker to ensure materials have correct information and documentation for seamless movement across country borders.
Whether your company needs to know the requirements for a specific transaction or a review of a project or workstream, we can help.