CFR Compliance LLC
Compliance, Regulatory & Quality Professionals
What We Do (scroll down)
STATE LICENSING
While the FDA oversees and sets regulations for the manufacturing and distribution of drugs and other healthcare products within the U.S. stream of commerce, some states have also implemented their own regulations to govern distribution within their state borders, complementing federal oversight. see our services.
DRUGS / BIOLOGICS
A drug is any substance (excluding food and water) that, when inhaled, injected, smoked, consumed, absorbed through a skin patch, or dissolved under the tongue, induces a physiological change in the body. Drugs can be either synthesized through chemical reactions or semi-synthesized from biological sources, with the latter classified as biologics. see our services.
MEDICAL DEVICES
A medical device is defined as any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including its components or accessories, that is intended for diagnosing disease or other conditions, or for curing, mitigating, treating, or preventing disease or other conditions.. see our services.
TOBACCO / HEMP / CBD
The FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. Instead, the FDA assesses new tobacco products using a public health standard that evaluates the risks and benefits to the entire population, including users, non-users, and considerations related to initiation and cessation. In contrast, products related to cannabinoids face a different regulatory framework, which depends on whether they are derived from hemp and their THC levels. These products are regulated by the FDA, but they are also subject to additional state-level regulations that govern taxation, usage, and medical prescriptions, such as those for medical marijuana. see our services.
EXPERT WITNESS
An expert witness is an individual whose specialized knowledge, gained through education, training, certification, skills, or experience, is recognized by the judge as authoritative in a particular subject matter. The judge may consider the expert witness’s opinion on evidence or facts presented in court within the expert's area of expertise. see our services.
HEALTHCARE COMPLIANCE
The Office of Inspector General (OIG) and the Department of Justice (DOJ) require hospitals, nursing homes, third-party billers, and durable medical equipment suppliers to establish and adhere to internal controls that ensure compliance with applicable statutes and regulations. This is particularly important for healthcare operations funded by federal programs such as Medicare and Medicaid. Both the OIG and DOJ enforce these requirements to prevent fraud, which could compromise patient safety and undermine government interests, see our services.
LABORATORIES (CLIA)
A “laboratory” or “clinical laboratory” refers to any facility engaged in the biological, microbiological, serological, chemical, immunological, hematological, biophysical, cytological, pathological, or other analyses of materials derived from the human body. The purpose of these examinations is to provide information for diagnosing, preventing, or treating diseases or impairments, as well as assessing the overall health of individuals, see our services.
COMPOUNDING PHARMACIES
Similar to drug companies, compounding pharmacies specialize in manufacturing substances (excluding food and water) that, when inhaled, injected, smoked, consumed, absorbed through a skin patch, or dissolved under the tongue, produce a physiological effect on the body, see our services.
COSMETICS / SUPPLEMENTS
A dietary supplement is a product intended for ingestion that includes a "dietary ingredient" meant to add nutritional value to or supplement the diet. A "dietary ingredient" can be a single substance or a combination of substances, such as a vitamin, mineral, herb, or other botanical. The FDA regulates both finished dietary supplement products and their ingredients under a separate set of regulations distinct from those for conventional foods and drug products. These regulations fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). see our services.
TRAINING / SPEAKING
Training involves teaching or developing skills and knowledge in oneself or others that relate to specific competencies. The primary goals of training are to enhance capability, capacity, productivity, and performance. see our services.