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