Many companies in the nicotine industry with NGPs are looking at alternative routes to bring their products to market. The medicinal product route is a well-deﬁned and pre-existing process that allows your product to be marketed as a cessation aid. The beneﬁts of obtaining a medicinal product license for your product are detailed below.
Consumers who are looking for a new product to help them quit smoking often fail because the cessation aide doesn’t deliver the level of nicotine they are used to. With increased strength, your vaping product can deliver enough satisfaction to start the cessation process. An increase in capacity allows the consumer to use your product with less reﬁll.
Many consumers have either not tried vaping products because of their concerns for safety or they have tried a vaping product and found it to be ineffective. By obtaining a medicinal product license, you will gain consumer’s conﬁdence in the delivery of a high-quality vaping product.
When a vaping product is licensed as a medicinal product, all advertising routes are allowed because of the health and cessation claims that can be applied. In addition, a medicinal licensed vaping product can be made available on prescription.
Most companies who decide to go down the Medicinal Product route are unfamiliar with the drug product submission process. Our team of highly qualiﬁed and experienced scientists and regulatory consultants guide you through the process. We manage all aspects of compiling the CTD (Common Technical Document) as well as post-marketing approval support. You will have a dedicated Project Manager who delivers effective communication and has a strong track record of meeting project deadlines. Combined with our regulatory consultancy, we help you reduce the lead time in getting your product to market by designing your strategy appropriately to minimize rework and satisfy the regulators.
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