Adopting best practices from the pharmaceutical industry for product quality control, promotion to physicians , professional communications, dealing with regulators, publicity, labeling, and safety.
Kotzker Consulting, LLC was founded by Joseph J Morgan, MD after over 20 year's of pharmaceutical industry experience.
The mission of Kotzker Consulting is to provide personalized, responsive, high-quality professional services for clarifying issues involving pharmaceuticals. Drug safety is our # 1 area of expertise. We have successfully characterized drug safety signals (shown many to be false and some to be true while clearly proving and describing why.) We also consult in the therapeutic areas involving our patent related interests and in other areas involving pharmaceuticals.
We have a US patent pending (and have filed in Canada, EU, Israel, and India) on "Use of cannabinoids and terpenes for organophosphate and carbamate toxicity." We believe this patent, based on original research by Dr Morgan, may be rapidly turned into an approved and lucrative pharmaceutical, without Phase 2/3 human testing, for preventing and treating nerve agent (organophosphate) toxicity based on the rarely used animal-only study pathway to FDA approval. Preliminary data was presented to the US Army Medical CounterMeasures Group and NIH. Since there is no FDA-approved therapy for pesticide related chronic toxicity or Organophosphate-Induced Delayed Neurotoxicity (OPIDN), we believe our products can be first and also be designated for Orphan and Fast Track status.
We have expertise with MARINOL (dronabinol, synthetic THC), other legal cannabinoids, and terpenes. We have pioneered non-Schedule l research methods with FDA-approved cannabinoids (with added food grade terpenes and/or hemp stalk CBD classified as a food). We consult on potential uses of these methods for basic science research and compounding personalized prescription recommendations (in DEA/FDA Schedule lll) to mimic medicinal properties generally associated with more restricted phytocannabinoids. We believe that a growing appreciation of the endocannabinoid system may lead to major advances in understanding health, chronic disease, the aging process, and reducing risks from certain side effects of medications and surgical procedures.
We work to serve your needs and desires. Ask us! We are a team of experienced physicians (including Internal Medicine), pharmacists and a natural products PhD chemist (see www.creativeaccord.com). We believe in working with our clients to maintain and improve their products, services, and health. We also believe inquiry, education, and freedom are necessary for optimal advancements in scientific research and a rational approach to therapeutics.