Development capabilities
Integrated development process
Iconovo is a fully integrated inhalation partner. We can take projects all the way from molecule to market, managing the entire journey from concept to finalized pharmaceutical product. But we are also open to the partner taking the lead in late-stage development and manufacturing of finished goods.
Our competitive edge lies in combining inhaler expertise with proficiency in dry powder formulation. We leverage five proprietary device platforms, optimizing them to match specific drug properties. Additionally, we manage the manufacturing of Clinical Trial Material (CTM) and handle full regulatory documentation. With all expertise in-house, we deliver an accelerated, cost-effective, and de-risked path to market.
Developing inhalation products is a complex multidisciplinary challenge requiring the seamless integration of chemistry, biology, mechanics, and aerodynamics. At Iconovo, we unify device design, formulation, and pharmaceutical analysis in a collaborative environment. This integrated cross-functional approach significantly reduces lead times, development costs, and project risks.
We operate state-of-the-art laboratories purpose-built for inhalation development. Our capabilities range from advanced CAD design tools to precision formulation equipment and full analytical characterization using NGI and HPLC methods.
Uncompromising quality is at the core of our operations. Iconovo’s Quality Management System is fully compliant with the medical device standard ISO 13485 and the FDA’s Quality System Regulation (21 CFR Part 820). Furthermore, our development of combination products adheres to FDA requirements (21 CFR 4) and follows all relevant EMA, FDA, and ICH guidelines.