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FDA Consulting

Because we are an FDA registered manufacturing facility, we are required by the FDA to follow good manufacturing practices (GMP's) but more than that, each and every drug product is regulated individually. That means that whenever a drug product is produced, it must have a currently-compliant label, the appropriate package, and be shipped appropriately. Everything about OTC drug products is regulated right down to the wording of the label. Even the environment the product is made in is the result of a system of regulations.

If your company is considering producing its own OTC drug products, we can help you get over the learning curve in a fraction of the time it would take you on your own. We can even act as your Quality Control Unit until you can find or train one of your own. We often test candidates for their ability to do this job and then report our findings to a company's HR department.

What is an OTC drug?

An OTC (Over The Counter) drug is any product that changes the form or function of living tissue. EG: There can never be a drug to treat hair after it has been grown because hair is not living tissue. You can, however, make the claim "hair growth" because that refers to the cells in the hair follicle that actually produce the hair. Some common drug claims for topical products include but are not limited to pain relief, itch relief, SPF (Sun Protection Factor), skin Protectant, relieves/cures [any medical condition], and acne treatment/prevention.

FDA Consultants Manage Risk

The whole purpose behind using an FDA consultant is to reduce the time to market while lowering the risk of releasing a new product into that market. Using FDA consultants to examine your formula, outline stability testing procedures and estimating time lines can help you coordinate the arrival of packaging materials and the printing and publishing of marketing pieces and websites so that they are ready at the same time. This can greatly improve the impact of every dollar spent effectively increasing your return on investment (ROI). If you are already setting up an FDA-registered facility of your own, an FDA consultant can act as a hostile FDA inspector. They can come into your facility, examine records, procedures, the layout of your property, and give you a mock-583 report that tells you everything you're doing wrong. Then we do what an FDA inspector won't do...tell you how to fix everything. Our consultants have been through many inspections themselves and they are constantly researching FDA procedures and inspector training programs.

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