Built by a Registered Manufacturer.
Trusted by Industry Innovators.
Our in-house consultants offer hands-on support—from registration and quality systems to labeling and SPL submission—so your team can focus on growth, not guesswork.
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ā FDA Registration Support
ā OTC Monograph Navigation
ā GMP System Design
ā Drug Master Files (DMFs)
ā Structured Product Labeling (SPL)
Registering with the FDA
Complying with Regulations
To produce and market pharmaceutical products, including prescription and over-the-counter (OTC) drug products, in the United States, a company must comply with the regulations set forth by the US Food and Drug Administration (FDA). This includes both FDA registration and FDA approval of the product, requiring significant investment, expertise, and a deep understanding of regulatory requirements.
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To register with the FDA, a company must provide basic information about its facility and the products they produce. However, to produce and sell products such as prescription and OTC drug products, a company must also be licensed as a pharmaceutical manufacturer. This involves complying with strict guidelines and regulations to ensure that the drugs are safe, effective, and of high quality.
The manufacturing process must follow Good Manufacturing Practices (GMP), which are established by the FDA to ensure the quality of drug products. These regulations cover all aspects of drug manufacturing, including the sourcing of raw materials, the manufacturing process itself, and the testing of the finished product.
Why Companies Choose EarthMed Over Traditional Consultants
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ā We’re not just consultants—we’re an FDA-registered manufacturer
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ā Decades of real-world, audit-ready experience
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ā Custom solutions tailored to OTC and drug compliance
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ā Faster, cleaner execution with reduced risk of delays or rejection