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PRACTICES |
International Regulatory and Legislative AdvocacyOverview: As companies develop a new product or substance, a primary goal is to bring the substance/product to market as quickly, efficiently, and cost effectively as possible. Standing between the client and success in the marketplace are regulatory hurdles and policy expectations that expand with the client’s international reach and product characteristics. In the U.S., European Union (EU), and Asia, there is a panoply of authorities to contend with, including the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), U.S. Food and Drug Administration (FDA), the European Chemicals Agency (ECHA), Member State authorities, China’s State Administration of Work Safety (SAWS), and China’s Ministry of Environmental Protection (MEP), among others. The task of navigating all the many authorities standing in the way of reaching the marketplace may be daunting, especially given the ever-changing regulatory landscape. The Acta Group (Acta®) provides critical and highly skilled guidance to help clients avoid the errors in regulatory compliance that can delay or derail commercialization of critically important substances/products, affecting significantly a company’s strategic plan and opportunities for success. Thanks to our significant legal and policy knowledge-base and network of government contacts in the U.S. and abroad, we are uniquely qualified to help client companies to product commercialization and beyond. Once our clients reach their markets, Acta helps them maintain their presence by guiding ongoing compliance needs as they change. We maintain a steady focus on our clients’ business purposes -- while working through and around policy imperatives. Our Experience: Acta offers clients a uniquely seasoned and expansive group of expert consultants located in the U.S., EU, and Asia. Our team is comprised of individuals with years of experience working with and within government, undertaking and overseeing regulatory completion for start-ups as well as major multinational corporations, and providing consulting and advocacy work for clients across the chemical, agricultural, and energy spheres (among others). We are legislative and regulatory consultants, business professionals, and scientists with the technical and policy know-how to understand -- and advocate for -- our clients’ commercial objectives and products’ regulatory needs. James V. Aidala brings years of experience in senior government positions at EPA, including the top EPA pesticide official as Assistant Administrator for what is now EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), after spending almost a decade working for various lawmakers on Capitol Hill on a variety of pesticide and chemical legislative issues. While at EPA, Mr. Aidala led the team charged with drafting (and shepherding enactment of) the Food Quality Protection Act (FQPA) and is keenly aware of all current pesticide issues. Jane S. Vergnes, Ph.D., DABT®, based in the United States, has 25 years of experience designing toxicology testing strategies to meet a wide variety of global regulatory requirements, including working with laboratories and regulatory agencies to adapt study plans to suit the chemical compound, the client’s marketing strategy, and the regional regulatory realities. Lara Hall, M.S., a Scientist and Registered Quality Assurance Professional for Good Laboratory Practice (RQAP GLP) based in the United States, assists clients in ensuring scientific integrity and regulatory compliance through all phases of data development to support new and existing product registrations worldwide and interfacing with a global network of regulatory officials. What We Do: Acta provides the expert resources clients need to get their products to market quickly and keep them there. We help clients obtain regulatory approval and work through the legislative process. We counsel and assist clients on how to best approach officials at regulatory agencies to ensure the most accurate scientific information and policy arguments are incorporated into pending decisions. Successful and meaningful interaction with officials is particularly important in evolving spaces, such as in the EU and China, where the regulatory framework is new to regulators and market entrants alike.
Representative Engagements:
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