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

Dosage Forms

Dosage Forms

Broad and extensive experience of development of all common dosage forms.

Equipment

Equipment

See our equipment for solid and semi-solid dosage forms.

Process Development

Process Development

Scalable manufacturing processes.

Our Business Model

Our Business Model

Galenica provide tailor-made business solutions and offers unique flexibility for our clients, with possibilities to either choose single parts of our service or a complete drug development program. Contact us here.

Business Model