We provide scientific drug development expertise in:

  • Drug substance and drug product development with experience from a broad range of drug substance classes and dosage forms
  • Support in development of a regulatory CMC strategy including e.g drug substance/product classification, starting material strategy, formulation strategy, bridging strategy, stability strategy, impurity control strategy, and validation strategy
  • Nonclinical strategy including design of nonclinical studies
  • Clinical development strategy including clinical study design with experience from major therapeutic areas, such as CNS, cancer, diabetes, rare diseases
  • Clinical pharmacology, pharmacokinetics, and drug-drug interactions