Jim Davis , R.Ph. MBA
Upon graduation from pharmacy school Jim began his career in quality control for a drug manufacturer. Over the next 14 years with that manufacturer he held management positions in quality control, manufacturing, shipping logistics, maintenance and technical services. He was responsible for plant pilot research and development, scale ups and national logistical roll outs of new products. He then spent 6 years at Shertech working in a low energy lab as a Nuclear Pharmacist and Compounding Pharmacist. In 2005, he became Plant Manager for Shertech Laboratories, the cyclotron facility that produces high energy PET products. High energy radio-pharmacies are under the review of the FDA which was a perfect fit for his background. He has currently overseen the submittal of three abbreviated New Drug Applications.
Jim has B.S. degrees in Chemistry and Pharmacy and a Master degree in Business Administration. The education and experience allows the offering of drug manufacturing, laboratory analysis and regulatory review.
Manufacturing and Packaging
When to consider Shertech Laboratories, LLC as YOUR contract packager:
- No available in-house equipment or expertise for a particular job
- Your facility is at full capacity
- YOU have a short run for a new product market test, gift pack or seasonal appeal
- Promoting YOUR product with non-standard packaging or promotional inserts
- YOUR product needs re-working to make it saleable
- Better performing non-food categories are pain remedies, cough and cold remedies and first aid.
- Store brand items have become increasingly popular across many product categories.
- Recessions often force consumers to test new purchasing habits
- Store brands retain recession-driven gains
- Pharmaceutical manufacturers are in the business of safely manufacturing large quantities of medicines, drugs and other pharmaceutical products and supplements.
- Shertech Laboratories, LLC works in strict compliance with laws governing safe manufacturing and legal distribution of pharmaceutical drugs.
- Reduce YOUR operating costs with bulk manufacturing from Shertech Laboratories, LLC
Nuclear Product Manufacturing
Nuclear Pharmaceutical Manufacturers are in the business of safely manufacturing, handling and transporting nuclear medicine.
Shertech Laboratories, LLC works in strict compliance with laws governing safe manufacturing and legal distribution of NUCLEAR bulk pharmaceutical drugs.
Reduce YOUR operating costs with NUCLEAR bulk manufacturing by Shertech Laboratories, LLC
Generic PET Drugs:
- Fludeoxyglucose F18
- Sodium Fluoride F-18
- Ammonia N 13
Specialty Manufacturing and Packaging
The alternative medical system of homeopathy was developed in Germany in the late 1700’s.
“Like cures like”—the notion that a disease can be cured by a substance that produces similar symptoms in healthy people
“Law of minimum dose”—the notion that the lower the dose of the medication, the greater its effectiveness
Homeopathic remedies are derived from substances that come from plants, minerals, or animals, such as red onion, arnica (mountain herb), crushed whole bees, white arsenic, poison ivy, belladonna (deadly nightshade), and stinging nettle.
Homeopathic remedies are often formulated as sugar pellets to be placed under the tongue; they may also be in other forms, such as ointments, gels, drops, creams, and tablets.
Homeopathic remedies are regulated as drugs under the Federal Food, Drug and Cosmetic Act (FDCA)
OTC drugs are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional such as a physician.
They can be purchased by consumers without a prescription.
These drugs are sometimes approved under applications like new prescription drugs, but more often they are legally marketed without an application by following a regulation called an OTC drug monograph.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers of nutritional supplements are responsible for ensuring that their products are safe before they are marketed.
Manufacturers of nutritional supplements do not need to provide information to the Food and Drug Administration Board, before they can get a product out on the market.
They do not need the board’s review & approval of a supplement’s ingredients before selling these products.
Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of the Federal Food, Drug, and Cosmetic Act4 (FD&C Act) and the Fair Packaging and Labeling Act5 (FPLA).
These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices, and to help consumers make informed decisions regarding product purchase.
It is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to regulatory action.