Our business model is to develop and commercialize topical and transdermal products based on our proprietary nanofiber technology. We will reformulate existing dermatology drugs to enhance their efficacy, while reducing side effects and improving product aesthetics. We will enable transdermal delivery of low solubility, poor absorption drugs and biologics, as an alternative or adjunct to injectable therapies.
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Step 1: pre-feasibility assesment
A pre-feasibility assessment report is completed under an NDA and assesses the technical compatibility of Agigma’s delivery system with the intended payload and the proposed product concept.
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Step 2: feasibility
Feasibility is established through a set of experiments to determine, through laboratory formulation and analysis, the compatibility of the compound/s with Agigma’s delivery system. During the feasibility phase, many aspects of the product concept and definition are taken into account. This work is based on defining formulations to assess technical compatibility for the payload and delivery system to meet the performance and marketing requirements defined by our partner.
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Step 3: development
The objective is to develop a technically and commercially viable product for marketing and sales by our partner with Agigma manufacturing and supplying the product. Our partner defines the product and the indication, conducts all necessary clinical studies and sets the marketing and sales strategy. Agigma and our partner jointly define the work plan which evolves over the course of development from pre-clinical to New Drug Application (NDA) or equivalent submission. Agigma will formulate and develop products, including scale-up manufacturing to launch product within the marketing timelines of our partner. This includes product formulation and stability testing, analytical method development, process development and scale-up to production. In addition, Agigma can assist with early clinical studies. All work is in compliance with cGMPs and global regulatory guidelines.
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Step 4: commercialization
Following scale-up and validation, Agigma works closely with our partner to meet their product launch objectives.
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