Regulatory Opinions

In the life sciences industry, precise regulatory and expert opinions are essential for making informed decisions and maintaining compliance. At Asebey Life Science Law, we leverage our deep scientific knowledge and legal expertise to provide tailored regulatory and expert opinions that address the unique needs of each client. Our scientifically-trained attorneys deliver clear guidance to empower clients to make informed decisions while navigating complex regulatory landscapes to achieve their business objectives. 

We offer a wide range of opinions, including FDA classification opinions for drugs, devices, and dietary ingredients, as well as regulatory pathway opinions for the approval of drugs and biologics.  Our expertise extends to advising on the lawful sale of GLP-1 receptor agonists for research purposes, hemp-derived cannabinoids, and exotic natural products for food and dietary supplements. We also provide cosmetic / drug classification opinions and state compliance opinions for cannabis products. Additionally, we serve as expert witnesses in mass tort cases, providing authoritative testimony based on our extensive knowledge and experience.

Our regulatory opinion services include:

  • FDA Classification Opinions (Drug, device, dietary ingredient)
  • Regulatory Pathway Opinions for approval of drugs and biologics (NDA, ANDA, 503(b), BLA, biosimilar)
  • Hemp-derived Cannabinoid Regulatory Opinions (Delta-9, Delta-8, THCa, etc.)
  • Compounding pharmacy business model Opinions
  • Exotic natural product regulatory Opinion (Food, Dietary Supplement)
  • Cosmetic / Drug Classification Opinions
  • Cannabis product state compliance opinion
  • Mass torts Expert Witness

Tell us more about your regulatory needs so we can help you succeed.

Request a consultation