Technical Development Strategy

Drug delivery device and component selection: Chimera assists clients in selecting the optimal drug delivery device and components for delivery of a particular drug or biological product. Device selection process depends on proper establishment of requirements specifications, the composition of the pharmaceutical formulation and knowledge of drug delivery device options. Once a delivery device is selected, pharmaceutical and functional compatibility performance and stability is assured through the proper selection of device component parts. All of these activities and assessments are within Chimera’s capability.

Pre-clinical: Chimera assists clients in appropriately designing preclinical toxicology and/or biocompatibility programs to properly address combination product pre-clinical safety requirements.

Clinical: Chimera assists clients in designing clinical development strategies and clinical study designs which take into account drug and device development paradigms, including Human Factors Engineering/Design Validation studies following clinical and simulated use protocols. Chimera advises clients on the proper application of investigational exemptions for the development of a particular combination product and can draft, assist in drafting, or review these documents prior to their submission.

Manufacturing and Controls: Chimera assists clients in designing stability programs to establish shelf-life and compatibility/suitability/extractables-leachables studies to assess chemical and physical interactions between combination product constituent parts. These assessments help to establish limits for substances that may leach from device or container-closure system components. In cases where a combination product contains more than one device, Chimera assists clients in establishing specifications to assure that tandem device systems remain fully functional and compatible throughout their shelf-life and in use. Chimera also assists in the preparation of CMC documentation to be included in marketing applications and Master Files.

technical, regulatory affairs, quality assurance, compliance consulting