Our expertise in quality matters will help you identify and overcome early challenges in your development journey.
- Development plans
- Analysis of the competitive landscape
- Selection of raw materials suppliers and specialised GMP, GLP and GCP compliant service providers
- Drug substance and drug product optimisation
- ASMF/DMF review and preparation support
- Quality and Non-clinical gap analysis
- Quality and Non-Clinical study protocol design
- Manufacturing process development and optimisation
- Report writing