In today's global marketplace, an understanding of international trade, foreign laws and regulations, and international standards is a must. Members of Keller and Heckman's international regulatory affairs practice group have extensive experience in helping clients understand how foreign laws and regulations, international trade agreements, and standard setting organizations affect their interests, and in advocating on their behalf to promote open markets across a diverse array of governmental, quasi-governmental and private organizations. By combining a thorough understanding of trade and regulatory policymaking with a technical knowledge of diverse laws and regulations, we successfully promote our clients' interests in the global marketplace.
Global marketers must deal not only with traditional trade issues such as customs duties, but also with an array of complex laws that can affect market access around the world. For example, product standards, package labeling requirements, environmental protection mandates, privacy laws and other international, regional or national regulations can effectively restrict a client's ability to conduct business in international markets. We assist clients in developing global best practices and other strategies to effectively respond to these requirements, calling on the experience and knowledge of our other practice groups and our scientific and technical staff as needed.
Keller and Heckman attorneys are experienced in handling food, drug, cosmetic and commodity issues, as well as environmental and chemical control issues involving the U.S. government, European Union, Eastern and Central Europe and other trading blocs, the World Trade Organization, and various committees of the Codex Alimentarius Commission, as well as in counseling clients on how to comply with technical product regulatory requirements in these as well as Pacific Rim, mid-Eastern and Mercosur countries. We also have experience in employing the principle of free movement of goods (mutual recognition), as embodied in articles 30 and 36 of the Treaty of Rome and to assist clients in finding alternative routes to market products internationally that they could not otherwise place in certain national markets.
Since 1992, Keller and Heckman clients conducting business in the European Union have been assisted by attorneys in the firm's Brussels office who are actively involved in issues relating to the integration of the regulatory regimes of the European Union. Our knowledge of the internal workings of the EU institutions enables us to guide clients through the complex EU regulatory system and advise clients regarding the applicability of EU legislation to their products and materials. Our attorneys enjoy a close working relationship with the European Institutions, through daily contacts with officials in the European Commission, the European Parliament, and the Council. Moreover, given that the harmonization of the laws of the Member States remains incomplete in many areas, our attorneys also advise our clients on the applicability of national legislation to their products and materials and, to that end, have developed extensive contacts with national authorities. Our attorneys also have more than 10 years of regular contact with Eastern and Central European authorities to advise them on harmonizing their legislation with that of the EU, and are therefore uniquely positioned to help our clients identify and address legal and regulatory challenges and opportunities in the forthcoming enlargement of the European Union to 13 more Member States.
To meet the rising demand for global regulatory advice in Asia, Keller and Heckman opened an office in Shanghai in December 2004. Our Shanghai office provides advice to clients on the intricacies of international regulations in the areas of foods, food packaging, drugs, dietary supplements, medical devices, pesticides and industrial and fine chemicals. We assist clients with the legal status of ingredients in products; the effects of local Asian standards; the necessity for pre-market clearance and how to obtain it; regulation of labeling, nutrition and health claims; advertising; hygiene and inspection requirements; and import/export certifications. Many of our lawyers firmwide have built relations over the years with various government officials, industry associations, and market research and financial firms. The firm is also a member of the Chinese Food Additives Association, the International Life Sciences Institute Focal Point in China, and the American Chamber of Commerce in Shanghai.
Following are examples of the issues handled by our International Regulatory Affairs Group:
Drugs, Medical Devices, and Cosmetics
Privacy and Internet
Advertising and Marketing
Other Regulatory Practices
Keller and Heckman's international regulatory affairs practice group has legal, technical, practical, political, and scientific experience in a broad range of international issues. From offices in the United States, Europe, and Asia, we help our clients identify and address legal and regulatory challenges in this fast-paced, ever changing global economy.
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