Consulting services
We bring our industrial experience in Drug Metabolism and Pharmacokinetics to help you define your drug development strategy and achieve your drug development objectives.
Our services cover, but are not restricted to:
- project management
- study design and reporting
- pharmacokinetic/toxicokinetic analysis
- regulatory document writing (e.g. IND, NDA)
- regulatory issues
- toxicity issues related to the metabolism of new chemical entities
- development of in-vitro assay procedures (e.g. in-vitro drug metabolism, drug transporters, drug interactions)
- development of bioanalytical methods
- data review and interpretation
- review of your spectral data and metabolite structure elucidation
- identification of contract research organisations (e.g. bioanalytical chemistry, clinical pharmacokinetics, in-vitro ADME screening)
- laboratory audits
- ADME training courses in your facilities
- due diligence assesments
- gap analysis