EngelNovitt

About EngelNovitt

EngelNovitt is an internationally-recognized boutique law firm whose reputation has been established through the provision of legal counsel, representation, and strategic advice to multinational and domestic pharmaceutical, biotechnology, and health care companies, biomedical researchers, academic institutions, health care providers, and patient advocates. With a global client base spanning Europe, the United States, and the Pacific Rim. EngelNovitt develops and implements forward-thinking science-based solutions to resolve complex scientific, science policy, legal/regulatory, legislative, public policy, and business issues affecting innovative industries in the firm's core practice areas relating to drugs, biologics, medical devices, and genomics. The firm has built a substantial international practice by anticipating emerging science policy, legal/regulatory, legislative, and policy developments and business conditions that will profoundly impact the future course of our clients' interests, particularly as they relate to interactions with policymakers, regulators, and other governmental authorities. In doing so, EngelNovitt differentiates itself from traditional law firms that spend most of their time operating exclusively in the past (e.g., by counseling primarily on compliance with existing regulatory requirements) based upon conventional business assumptions and existing governmental regulatory schemes. EngelNovitt takes pride in its ability to anticipate and forecast critical policy trends and legal/regulatory developments, and thereby leverage the opportunity to devise and implement creative strategies that facilitate a forward-looking approach to maximize the strategic business objectives of our clients. EngelNovitt supports the innovative biopharmaceuticals and life sciences industries by addressing critical issues affecting it also distinguishes us from other firms, as we apply a solutions-oriented approach to develop multiple, complementary strategies to address real-world product development, approval, and governmental oversight challenges confronting our clients. We recognize that regulatory agencies and the regulatory paradigms they oversee do not exist in a vacuum but are subject to a variety of influences from other governmental entities, industry, and the public. Accordingly, EngelNovitt leverages a strong, science-oriented, background in academia, government, and biopharmaceutical industry research and development, supplement as warranted with strategic partners, including public relations specialists, lobbyists, and highly-experienced marketing executives. The firm's combination of expertise and experience in food and drug law, science policy, regulatory affairs, healthcare policy, and legislation - combined with over 25 years of experience working in a myriad of therapeutic areas - allows us to have a thorough understanding of complex issues and offers our clients an opportunity for coordinated action in several areas. It also has positioned EngelNovitt as a premier boutique firm working in the following highly-specialized practice areas: Drug, Biologic, and Device Development, Approval, And Regulation The law firm's practice before the United States Food and Drug Administration ("FDA") covers all aspects of the research, preclinical and clinical development, approval, manufacturing, distribution, promotion, and marketing of innovative drugs, biologics, and medical devices. We routinely are engaged to provide assistance in product development - including clinical trial design, informed consent, and good clinical practices - as well as advice on obtaining FDA approval of products, especially those that have encountered difficulties in the development or approval process. The firm has a clear understanding of the best ways in which to leverage science as well as laws and regulations to meet business objectives. They also understand the roles that competitors, Congress, government agencies, and advocates can play in affecting the regulatory process, and have successfully organized coalitions that include patient groups, physician organizations, and industry. These collaborative efforts have focused on specific, short-term product issues as well as long-term public policy activities. Science Policy Initiatives And Legislation EngelNovitt handles an array of technical scientific, science policy, and legislative assignments within the health care arena. Our work is distinguished from that of traditional Washington-based lobbyists by an attention to substantive scientific and legal/regulatory detail, and by respect for the influence of government agencies, consumer and other advocacy groups, and other non-legislative forces on the legislative process. As a result, the firm can increase the probability of success and expand the financial upside of a business strategy by supplying the appropriate scientific guidance, political packaging, and substantive policy strategies. Product Life Cycle Manag