About

Ardena is a specialist CDMO and bioanalytical CRO dedicated to navigating complex drug development challenges. With a comprehensive suite of integrated services, we streamline the pathway from molecule discovery to clinical trials, reducing time-to-clinic while maintaining the highest standards of quality and compliance.

Our expertise spans small-molecule API projects, including route scouting, development, and accelerated manufacturing, with capabilities for high-potency APIs (HPAPIs). We offer phase-appropriate drug product development, bioavailability enhancement, and advanced manufacturing solutions, tailored to the needs of each development stage.

Ardena is also a leader in nanomedicine development and manufacturing, delivering cutting-edge solutions to enhance drug delivery and therapeutic efficacy.

Our comprehensive bioanalytical expertise includes a broad range of testing and validation services, supported by state-of-the-art facilities and a team of experienced scientists. We provide expert CMC regulatory support, embedding compliance into every aspect of drug development to ensure that all projects meet international standards and are submission-ready.

With international facilities strategically located in Belgium (Ghent), the Netherlands (Oss and Assen), Spain (Pamplona), Sweden (Södertälje), and the United States (Somerset, NJ), Ardena offers global reach combined with local expertise. This network allows us to provide seamless support across regions, efficiently managing complex logistics and regulatory requirements.

What sets Ardena apart is our agile, multidisciplinary platform. We understand that early-phase drug development is dynamic and often requires quick pivots. Our adaptable operations allow us to efficiently respond to changing project requirements, minimizing risks and maintaining momentum.

Ardena combines deep scientific expertise with personalized client support. Our focus is on building collaborative partnerships, where our technical knowledge and strategic insights guide clients through the complexities of drug development.

With a commitment to excellence and a track record of successful projects, Ardena is the partner of choice for biotech and pharmaceutical companies aiming to bring innovative therapies to market efficiently and effectively.

Ardena is a leading Contract Development and Manufacturing Organization in advanced drug development of new, innovative, and complex molecules. Ardena’s mission is to enable current and next-generation therapies to get into the clinic and to patients faster.

Ardena assists biopharmaceutical companies in navigating through the drug discovery and development process to create effective and compliant drug substances and products for clinical trials, by providing integrated services including solid state chemistry, API, and nanomedicine development and manufacturing, analytical and formulation development, drug product manufacturing, bioanalytical and CMC regulatory services.