Dorizoe offers proven expertise in providing regulatory-compliant product development services for the following dosage forms:
In all of our development programs, we adopt a Quality by Design (QbD) approach, applying and challenging possible technologies and techniques in order to deliver the optimal product profile and performance in a timely and efficient manner. We have capability for early stage API characterization, formulation, and analytical development through to process development, scale-up, and technology transfer for commercial manufacturing. We also support 505(b)(2) regulatory pathways. Our facilities and teams are designed to provide you the greatest flexibility while maintaining quality services.
Our inhalation product development team has good experience in formulating solution and suspension based dosage forms. Services available include dosage form selection, formulation development, and product performance testing of prototype formulations. Formulation selection and optimization are aided by statistical experimental design. We can also support selecting a suitable delivery device as part of the product development program. Alternatively, devices selected or developed by the sponsor can be evaluated to compare it with a marketed product.
We have developed a wealth of experience around analytical testing of inhaled products. Analytical method development, validation, and testing services are provided to support all phases of product development, from feasibility through regulatory submission. Key tests include:
We welcome the opportunity to discuss inhalation product development opportunities and how our proven expertise and technologies can help mitigate the risk and increase the probability of success.