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ARDENA accelerates your drug product development, bringing together the drug substance, the drug product and the bioanalytical capabilities needed for your project.
We provide standalone and integrate serves delivering solid state research, drug substance and product development, manufacturing, logistics, and (bio)analytical services to pharmaceutical customers globally. In parallel, we work with you to compile your regulatory dossier and to fast track your product towards compliance. Ardena is your one-source contractor for the chemical and pharmaceutical development of your valued compounds.
Ardena Solid State Research is specialized in the optimization of the drug substance physical forms including salts, polymorphs, amorphous forms and co-crystals. Our services also include pre-formulation activities such as solubility, stability and excipient compatibility studies.
Ardena Drug Substance Development and Manufacturing provides process and analytical development, GMP manufacturing, release and stability testing services. Our expertise and capabilities includes complex multi-steps synthesis route, a broad array of chromatographic purification techniques, and falling film distillation.
Ardena Drug Product Development & Manufacturing provides contract services in drug product formulation development, analytical development, early-phase clinical material manufacturing, stability studies and clinical packaging & clinical labeling.
Ardena Dossier Development assists in CMC regulatory dossier development from data review, data interpretation & scientific reporting, regulatory dossier writing & formatting and submission to post marketing regulatory support.
Ardena is a global leader in nanomedicine and nanoformulation development. Our nanomedicine expertise encompasses formulation, process and analytical development, GMP manufacturing and dossier development.