GenericPioneers

With over three decades of expertise in innovator product development, OzUK offers profound insights into the nuanced landscape of generic inhalation MDIs. Leveraging our comprehensive knowledge in formulation design, CMC documentation, stability requirements, scale-up, comparative studies, and regulatory nuances, OzUK is your strategic partner for developing innovative generics. Through our MDISprint methodology, we provide a full development package, breaking down the process into discrete work packages, including regulatory compliance, innovator characterisation, formulation design, package compatibility, early-phase stability, <601> and ICH testing, scale-up, and dedicated ANDA support.

In addition, OzUK extends its support further with expertise in in vitro bioequivalence to expedite registration, comprehensive clinical trial support, seamless scale-up strategies, and the efficient registration of filling lines. Moreover, our strategic partnerships with CDMOs ensure a seamless transition to commercial manufacturing, enhancing the overall efficiency and success of your generic inhalation MDIs.