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, 30º, 60%)
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