Maintaining timelines and
ensuring transparency to
guarantee project success
Selection of the API material based on several conditions:
- Documentation quality (DMF)
- Impurity profiles
- Stability studies
1 - 3 months
Galenic development:
- Formula development
- Dissolution profiles
- Stability studies
3 - 4 months
Performing stability studies:
- Accelerated (3 months, 40ºC and 75% HR)
- Long term (6 months, 30ºC and 60% HR)
3 - 6 months
Performing bioequivalence in fed and fasting conditions depending on the nature of the molecule
4 months
Complete dossier compilation
1 month
Registration of dossier to obtain production and commercialisation rights in respective country
3 - 18 months
Acquire commercialisation rights by presenting pricing scheme for approval
3 months