We pioneer drug/device combination product development and testing of OINDPs (nasal sprays, nebulizers, soft mist, and dry powder inhalers). In particular, we have deep know-how in the development and testing of soft mist and dry powder inhalers. We offer turnkey services in development and testing of analytical method development, validation and testing as per USP/EP methods. Typical OINDP specific test methods that we support are shown in the table below.
With many years of experience in the inhalation field, Kenox has developed a time and cost-effective integrated package for preclinical development of NCEs or repurposed molecules (505(b)(2)) into intranasal and inhaled products (see flow chart below). This model ideally suits early start-ups, virtual players, academic institutions, investors (venture capitalists, private equity players), or specialty players in their pursuit of developing novel and improved therapeutics.
In addition to complete development, we offer turnkey services including GAP analysis for NDA filing, asset evaluation & due diligence, ADME – candidate selection & early phase development, Clinical pharmacology studies – design, data interpretation & next steps and DDI guidance & execution of in vitro/in vivo studies.
We collectively have over 20 years of proven experience in the development, and hands-on experience in the development, submission, and approvals of a number of OINDPs include highly complex DPIs, Advair (fluticasone/salmeterol) and Symbicort (budesonide/formoterol) generics. We are pleased to offer generic product development and IVBE testing support, as shown in the flow chart below.
Please feel free to contact us at bd@kenoxpharma.us if you want to discuss your needs in detail.
