Dunlap Bennett & Ludwig lawyers have both practical business experience and legal experience advising clients in a variety of areas involving pharmaceutical, biotechnology, medical device, and life sciences research law. Our work includes advice on health care products advertising, conducting clinical trials and research, regulatory compliance, governmental investigations and defense, False Claims Act defense, product liability defense, licensing & intellectual property, labor, employment, and business transactions.

 

From experienced patent attorneys with masters degrees in biotechnology, degrees in chemistry and even attorneys who themselves hold inventive patent rights and have founded successful a biotechnology company, our intellectual property lawyers work hand in hand with our regulatory team.  Our FDA regulatory experience includes responding to FDA Warning Letters and Untitled Letters, to advice on cosmetic labeling under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) our lawyers can help before or after an issue arises. Distributing and manufacturing healthcare products requires understanding and managing the complex set of regulations under a number of state and federal agencies simultaneously including, the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and state Attorneys General (AG), which manage and enforce laws relating to:

  • Biologics
  • Cosmetics
  • Dietary supplements
  • Foods & food additives
  • Healthcare software
  • Health & wellness software
  • Homeopathic remedies and drugs
  • Medical devices
  • Medical foods
  • Medical mobile apps
  • Nutraceuticals
  • Over the counter (OTC) drugs
  • Stem cell products

Our corporate and transactional lawyers work closely with our FDA and intellectual property lawyers when it comes to handling corporate transactions involving due diligence in biotechnology and life sciences, with experience in preparing and completing all aspects of private equity and Series A and B funding rounds.