FDA drug registration by Tobias system Tobias System has been one of the most prominent companies that have been helping foreign clients to get FDA drug registration in an easy and hassle free manner. Our company provides services pertaining to DMF filings, ANDA filings and registration in structured product labeling. Manager of Tobias system has announced that the services have been extended to cosmetics, food and medical devices in recent times. In cosmetics, the company might not require FDA approval however it is important to get permission for the products that have color additives. Our company will work with the customers and help them to meet the stringent regulations stipulated by FDA.
All ingredients used by the cosmetic product should not have adverse effect on the consumers. Moreover the product should be labeled with absolute clarity without any hassles. Ingredients forming integral parts of the cosmetic should not in any case cause adulteration of the product. The company must ensure that the cosmetic doesn’t fall into the drug category.
NDC number is provided by the FDA department in case of drug or medical instruments trade. We help the importer to get the pre market approval from the government. Prior to the approval, the company should provide scientific proof that the product is safe and effective to be used by the customers. Devices are divided into class I and class II depending on their utilities. A rule called 510(K) is formulated that requires the sponsor to prove that the device is similar to other device in the market as far as performance is concerned.
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