Supporting your team in applying the latest technologies and strategies to accelerate development
Services include:
- Applying strategies to accelerate product development, global submissions, commercialization, launch and product life cycle
- Using AI to optimize processes, manufacturing and resolve technical issues
- Analytical method development, validation, development
- Preparation of reports and global CMC sections
- Statistical analysis/Product Shelf-Life predictions
- Dissolution support (BCS Classes 1-4, extended release, and Spray Dried Dispersion formulations)
- Impurity isolation, characterization, synthesis
- CRO and CDMO recommendations and management
- Building Quality Management Systems
- Auditing and preparing for PAI and regulatory inspections
- Training and workshops on current and pending regulations