Strategic Representation for Companies in the FDA Space
Baker Jenner collaborates with pharmaceutical, biotech, medical device, nutraceutical and other companies and firms to formulate innovative approaches and solutions to their business, deal formation, contract performance, and regulatory needs. With significant in-house experience, we understand the balance our clients must maintain between growth and product objectives, risk management, investor and other needs.
Whether generic or branded, firms falling under FDA exist in a highly regulated space,with complex needs at every level. From quality control to labeling, product promotion and more, a core challenge remains how to turn reams of rules, regulations, and guidance into practical policies that protect the business while still advancing its strategic objectives.
Everything Seems Like It’s Coming Together…
You have assembled the right team, run the right models, and focused on the right products and ideas. Customers like what you have and are buying inventory. TRx and NRx data are promising, and you’re in talks with new technology and product partners who can help you hone your competitive edge. But as your business prospers there are also problems, including:
- Crafting,documenting, and implementing policies that satisfy FDA requirements and best practices, without drowning departments and stymying the agility you need for success
- Volumes of laws, statutes, regulations, rules and guidance that impact almost every level of the business,add endless complexity, and drain resources with little return restrictions on product promotion that seem to straightjacket creative approaches and harm efforts at product differentiation
- Competitors attacking products and threatening legal action
- Protecting key intellectual property assets, relationships, tradesecrets, and confidential information
- Complex, multipart contracts that divert significant resources and take inordinate amounts of time to negotiate and close
The Challenge, in a Nutshell
Manufacturers, distributors, wholesalers, and others falling under FDA are confronted with the routine challenges of running a business. However, they must also contend with an expansive body of laws, rules, and regulations that add significant complexity to almost every aspect of their operations. Whether pharmaceutical, medical device, biologic or nutraceutical, satisfying the priorities of regulators while meeting growth and other key metrics remains a persistent necessity.
You need:
- A partner who will work with you to fashion defensible product and promotional claims that satisfy regulatory demands while meeting the need for a robust narrative
- Attorneys with experience in product development and labeling, orphan drug, product lifecycle management, compliance, and other areas critical to the business
- A law firm that understands the need for sound policies and advice that support business and product development
- An ally in negotiating and closing M&A, licensing, distribution, development, customer, and other contracts
Baker Jenner Can Be Your Advisors and Advocates
We work with our clients in everything from helping negotiate product development and manufacturing agreements, to licensing, promotional claims and commercial free speech. Baker Jenner’s clients include participants at every level in the industry, including contract research organizations, testing laboratories, manufacturers, wholesalers, and more.
From practical considerations, like promotional claims and the training of sales representatives, to manufacturing, user fees, and commercial-free speech, Baker Jenner helps businesses meet their strategic and product objectives. With key in-house and communications experience, Baker Jenner’s attorneys know food and drug law from the business perspective, and we understand the unique concerns and challenges you face.
