Ardena, a fully integrated Contract Development and Manufacturing Organization (CDMO), is dedicated to assisting companies in developing innovative drugs and advancing their molecules into clinical trials. Operating across five facilities throughout Europe, we provide a comprehensive range of services spanning from the development and manufacturing of the active substance and drug to the compilation of the quality module of the dossier and the analysis of biomarkers from clinical trials.

Our expertise lies in pharmaceutical product development and manufacturing across all phases, with a focus on enhancing bioavailability and capabilities in handling controlled substances and High Potency Active Pharmaceutical Ingredients (HPAPI). Additionally, we offer comprehensive services in the development and manufacturing of pharmaceutical products, along with expertise in logistics and packaging for clinical trials. We take pride in offering robust regulatory support in Chemistry, Manufacturing, and Controls (CMC), and excel in the development and manufacturing of nanomedicines.

The seamless integration of our services on a multidisciplinary platform allows us to effectively mitigate development risks, ensuring smooth project execution and ultimately reducing the time and cost to bring drugs to the clinical phase.

Recognizing the critical importance of each stage in drug development, we understand precisely what is needed at each phase. We apply appropriate quality standards based on the development phase, ensuring that our services align with the specific regulatory requirements of each clinical phase.

Our approach to drug development and manufacturing revolves around the requirements for preparing the necessary documentation for clinical trial approval, reflecting our commitment and expertise in complying with regulatory guidelines from the outset of drug development. When designing experiments and products, we consider regulatory requirements from the beginning, ensuring compliance at all stages of the process.

At our Pamplona facility, with a qualified team of over 100 professionals, we handle the development and manufacturing of solid oral dosage forms for both clinical development and commercial use. Our facilities include dedicated spaces for handling high-potency substances and controlled substances. Another fundamental area of expertise is improving the bioavailability of poorly soluble active substances through the use of advanced equipment, such as spray drying, from early development stages to scaling up and manufacturing for clinical trials.

In summary, Ardena stands as a leader in the drug development and manufacturing industry, offering a comprehensive and flexible approach that addresses the complexities and challenges of pharmaceutical development. Our unique combination of technical expertise, operational agility, and dedication to regulatory excellence positions us as a trusted partner for those seeking to successfully bring promising molecules from the discovery phase to the clinic.