CMC- Formulation Development

In the formulation development of pharmaceutical products, selecting the appropriate formulation is crucial for maintaining the stability of the active pharmaceutical ingredient (API) throughout its shelf life at the desired storage temperature. This choice should be guided not only by the desired product characteristics but also by the manufacturing process to be employed and by the desired root of administration of the product. Moreover, excipients should ideally be those readily available from multiple suppliers and listed in the Inactive Ingredient Database (IID), ensuring both regulatory compliance and supply chain reliability. By focusing on these criteria, developers can enhance product performance and longevity, ultimately contributing to patient safety and efficacy.

At Tandem BioPharma CMC Consulting services we bring large expertise in the formulation development for most of the available roots of administration, helping you to choose the right excipients from the start and by that reducing development time and ensuring product stability throughout its shelf life.