As new therapies emerge in oncology, rare diseases, cell and gene therapies, and advanced biologics, the injectable drug development pathway increasingly spans continents. A program that begins in the United States may need to transition into the European Union for regulatory submissions, clinical trials, or manufacturing support. Along the way, innovators may face shifting tariffs, complex logistics, and region-specific regulatory nuances, all while trying to maintain sterility, stability, and speed. For sponsors navigating these pressures, global fluency is not a convenience, but can be a critical success factor.
The stakes for injectables are particularly high. These products demand more than scientific rigor; they require flawless execution across supply chains and regulatory systems. A mislabeled shipment, a disrupted cold chain, or a misinterpreted regulatory requirement can derail months of work and jeopardize clinical timelines. Unlike oral solids, injectables have no margin for error when it comes to maintaining product integrity and clinical readiness. This makes the choice of CDMO partner especially consequential.
Most contract partners can deliver within their own borders, but understandably, many can struggle to align international operations into a single, seamless program. The result is often fragmented communication, delayed tech transfers, and unnecessary duplication of effort. That’s why forward-thinking innovators are seeking CDMOs designed for global continuity – organizations that combine early-phase development expertise with true cross-border infrastructure.
In the following article, we explore how Singota Solutions has built a model around this very need. With headquarters in Bloomington, Indiana and 3 strategically positioned facilities in Switzerland and Italy (Basel, Switzerland, Balerna, Switzerland, and Rovello Porro, Italy), Singota offers a rare blend of scientific expertise, strategic precision, supply chain resilience, and regulatory agility across continents. The piece highlights the benefits of global injectable innovation, and how the right CDMO partner can help ensure that promising therapies cross borders as seamlessly as they cross from concept to clinical.