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EngelNovitt, PLLC ("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 uniquely supports the innovative biopharmaceuticals and life sciences industries by addressing critical issues affecting leaders in these industries. This distinguishes EngelNovitt 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.

Our combination of expertise and experience in food and drug law, science policy, regulatory affairs, healthcare policy, and legislation - combined with decades 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. EngelNovitt 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 Management

EngelNovitt specializes in developing and implementing sophisticated strategies for lawfully maintaining, enhancing, and extending the life cycle of innovative products. The firm understand the novel relationship of intellectual property laws, the non-patent exclusivity provisions of the Hatch-Waxman Act and the Orphan Drug Act, and the extensive array of pharmaceutical regulations. The firm has creatively developed and implemented many successful life cycle management strategies based on these and similar tools.

Technology Transfer

EngelNovitt is a national leader in formulating creative ways to unite the sometimes competing interests of the innovative industry, government, and the academic community, especially with respect to development and transfer of technology through licenses, material transfer agreements (MTAs), cooperative research and development agreements (CRADAs), and clinical trial agreements (CTAs). The firm's founder has participated in many of the highest-profile and most successful technology transfer projects involving the National Institutes of Health (NIH), research institutions, and private industry.

Administrative Litigation

EngelNovitt has substantial experience in administrative and judicial litigation. The law firm accepts a limited number of cases involving challenges to governmental agency action under the Administrative Procedure Act ("APA") and the release of agency records under the Freedom of Information Act ("FOIA"), and the firm regularly provides key substantive assistance to traditional litigation firms in developing and implementing complex civil litigation strategies involving product liability and antitrust issues.

Due Diligence Reviews

In an era of consolidation within the innovative pharmaceutical and biotech industries, the expertise of EngelNovitt uniquely positions the law firm to evaluate FDA-related scientific and regulatory issues raised in connection with proposed corporate transactions and regulatory filings..

2401 Pennsylvania Avenue, N.W., Suite 310
Washington, D.C. 20037
Telephone +1.202.207.3300 - Facsimile +1.202.207.3318 - email: < engelnovitt AT engelnovitt.com >