Over a decade of GMP manufacturing experience

Ardena produces both preclinical and cGMP-compliant clinical batches. Our state-of-the-art facility combined with rigorous quality control measures ensures production of the highest-quality material that is fully compliant with cGMP requirements. We are particularly experienced in early clinical development of a program, bringing molecules from the lab bench to first-in-human studies. When we collaborate on a project, our experienced process development team will streamline the process, ensure its scalability and identify critical process parameters based on current practices in the industry.

In parallel, our team of analytical experts identifies and develops analytical methods following the latest ICH guidelines, instilling confidence in regulatory authorities regarding the quality of your product. This is especially crucial for complex formulations such as nanomedicines, where comprehensive analytical characterization is essential — often in-depth analysis is required for DS and novel excipients.

We specialize in navigating the intricate landscape of nanomedicine regulations and guidelines. With our experienced QA and CMC Regulatory Affairs teams in control, we have the expertise and insight to safely guide your nanomedicine through the complex regulatory pathway, ensuring its successful advancement into the clinic and beyond.