Combination product development/ Device selection/ CMC data

From over 20 years of experience in drug product development, an experienced team can support your development of combination products for inhalation from selection of API through to commercialization. This includes formulation and process development, device selection, scale up support and generation of all CMC data required.

Analytical methods

• Development and validation

RLD characterization

• Definition of development target
• Testing of RLD batches

Process and Transfer

• Development in lab scale
• Scale up and transfer to client or CMO
• Support up to final scale

Device selection and combination product

• Comprehensive process for device selection
• Support for MDR documentation
• DPI, MDI, nebulizer, nasals
• Risk assessment (FMEA)