Dry powder Inhalers (DPIs), pressurized Metered Dose Inhalers (MDIs), and Nasal drug products are complex delivery systems and their development requires key specialized expertise. To this end, Gateway Analytical and Next Breath are pleased to announce a strategic partnership to provide drug developers with analytical and product development support from R&D through submission and batch release for Abbreviated New Drug Applications (ANDAs-generics), New Product Applications (NDAs), and 505(b)(2) products.
This partnership will provide strategic and streamlined analytical guidance for developers of generic and new products. Next Breath and Gateway will leverage their complementary services to create customized development packages focusing on container closure screening, API selection, deformulation (reverse engineering) support, and complete CMC characterization including stability.
Comprehensive Development Support
No matter what phase of the drug development process you are in, from R&D through submission, our analytical services can support you each step of the way. Below is a listing of our combined comprehensive services for pMDIs, DPIs and Nasal drug products.
If you are interested in our automated particulate identification and characterization services please request a quote.