Product Development

Product Development

Development activities include early stage formulation and analytical development, technology transfer, scale-up, process validation, and stability testing, CRO selection, and clinical study design.

With pharmaceutical development, we monitor all development steps including:

API manufacture: Selection of API manufacturer ensuring supply of patent-non-infringing API, audit of API manufacturing site, assessment of CEP or DMF.

Product manufacturing: Qualification of finished product manufacturing sites for technology transfer, scale-up, process validation, and commercial supply.

Monitoring: Monitoring of preformulation and formulation trials to achieve patent-non-infringing formulation.

Analytical: Analytical method development.

Clinical studies: Management of BE and clinical studies.

Raw data collection: Raw data collection, evaluation, and dossier preparation.