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