Legal Elite Awards 2021

8 | Legal Elite Awards 2021 Apr21755 Penn Avenue Law & Policy is a specialist Food and Drug law firm that helps its clients through the crucible of regulatory practice in its industry. Working hard to serve businesses and the public by bringing new products onto the market with experience and dedication, its work has made it a significant voice for the sector. Best Specialty Law Firm 2021 - Washington D.C. legal company focusing on the specific sector of food and drug law, Penn Avenue Law & Policy is a company whose services encompass devices, diagnostics, digital health, genetics and genomics, wellness, and the advertisement and promotion of these products and services. The CEO and founder of this legal firm, Christine P. Bump, has over 15 years of experience in the field of devices and diagnostics, which gives her a unique insight into handling cases that fall within this realm. Furthermore, Christine has developed regulatory strategies for cutting edge and emerging technologies that wish to break into the food and drug sector, including where the FDA’s jurisdiction is unclear. The firm has represented a myriad of clients, including start-ups, mid-sized businesses, and enterprise level corporations. In addition, these clients span a wide geographical area, from the United States to all over Europe; this has ensured that Penn Avenue is well versed in all manner of regional legalese, able to advise its clients on everything from clinical investigations, FDA pre-market submissions, compliance with FDA requirements, and promotional problems. By making use of Penn Avenue’s regulatory strategies, it helps clients mitigate the risk of a business move, including for products in digital health or wellness. Fundamentally, it provides timely, personalised service, empowered by years of knowledge. Its portfolio is wide and variant, and Christine and her staff are diligent and rigorous when it comes to case research, including the consideration of legal and regulatory requirements that are directly relevant to a client’s goals. In this way, it provides a bespoke service that fits each client – to Penn Avenue, ensuring alignment with their business’s goals is of vital importance in a way that is unladen by unnecessary amounts of jargon or legalese. This is especially prevalent when discussing regulatory strategy. At present, many of Penn Avenue’s clientele have been developing, manufacturing, and marketing products that have been directly focused on helping healthcare professionals and the general public through the outbreak of Covid-19. Whilst the country, and indeed the world, has experienced health crises before, the scale and impact of the current outbreak has shaken the industry to its core and been a blow to the modern FDA and U.S. regulatory system, as it realised that many of its preceding guidelines were not equipped for the virus. In response, the FDA had been issuing further guidance and updates at an unprecedented rate that has become perplexing for emerging businesses trying to understand diagnostic, device, and health care industry standards. This has proven a challenge for Penn Avenue; but one that it has stepped up to the plate to meet as its workload began to pile up, consistently keeping a finger on the pulse of these highly changeable regulatory trends. Although in many large law firms, Food and Drug Law is a single practice area, at Penn Avenue it is treated with the complexity and attention to detail befitting a sector where different products and food types are all under different regulations. It is not ‘one size fits all’. Thus, Christine has combined the granular nature of a small Food and Drug boutique firm, with the professional rigour of a large international law firm – both of which she has experience in – to create Penn Avenue. Going forward, it will be continuing to serve its clientele with niche solutions focusing on the nitty gritty of its sector in order to grant a client one-on-one service with a senior, experienced attorney. Christine has seen this work help so many people in the past; and hopes that in the future, many more can say the same. Company: Penn Avenue Law & Policy Contact: Christine P. Bump Website: A By making use of Penn Avenue’s regulatory strategies, it helps clients mitigate the risk of a business move, including for products in digital health or wellness.