Our client is currently seeking a Packaging Stability Subject Matter Expert to assist with a series of questions regarding the Packaging Stability Program for their Oral Solid Dosage product. The contractor will need direct experience with packaging formulations, commercial packaging, registration stabilities within pharma, OSD products, and CMC Regulatory are all required for this position. Prior project experience with similar studies and successful completion of stability discrepancies is also mandatory. The consultation will include questions circulating around matters that should be considered when designing a formal stability study to support a product that will be supplied in a large quantity bottle configuration from which the pharmacist will sub-dispense the patient prescription into a general US pharmacy bottle. The client will need advisory on the pharmacy bottle configuration, if any in-use stability study is required, advise on if prescription 30-day supply feedback, probability of bracketing bottle size to begin stability studies prior to final selection, etc.
Duration: Ad-hoc / ~10hrs
Start Date: Targeting December 5th
Remote: Packaging Stability SME (232140)