Applied Pharma Research s.a. services

Pre-formulation development: physical and chemical characteristics of the proposed drug are analyzed to allow selection of optimal excipients and dosage forms. Formulation design: based on the product`s physicochemical/release characteristics and other important aspects, a range of theoretical formulations is proposed to determine how they affect the final product`s characteristics such as in vitro/in vivo performance and stability.

APR manages all steps in the transfer to GMP facility (technical and analytical transfers) and the activities are the following: Up-scaling: Usually, before the preparation of the GMP Batch, it is necessary the preparation of an up-scaled batch. Production of batch according to GMP for clinical purpose: If required a GMP Batch for a clinical purpose is manufactured as well as the formal analytical validations. On the GMP Batch a stability study according to the ICH guidelines is then performed. Validation: is completed with the manufacture of three validation batches.

APR has a dedicated clinical department that is involved in all stages of the clinical trial program from designing protocols to supervision, monitoring and conduction of clinical studies. We work with a network of existing partners or those selected by our clients.