Formulation development

Flexible approach for formulation development.

Flexible approach for formulation development.

We apply a scientific and yet flexible approach for formulation development required for efficient IND application.

Our scientists are highly experienced in Design of Experiments (DoE) and risk assessment applied in development of robust qualitative and quantitative formulations. We help over-coming complex formulation challenges, i.e. stability, bioavailability, process.

We use state-of-the art equipment in lab and pilot scale.

We support placebo development.

We provide regulatory CMC dossier support, IND/IMPD, NDA/ANDA etc.

Preformulation is a critical activity often overlooked in the development of new or existing pharmaceuticals. We are aware of the importance of relevant preformulation activities required for right-first-time guidance in pharmaceutical product development, i.e.

• Polymorphism
• Salt selection
• Compatibility studies
• Hygroscopicity Studies
• Solubility Determination
• Photostability of API
• Prototype evaluations