Clinical expertise enhances commercial packaging solution
Sharp Clinical Services in the UK started working with a client in May 2011 when they were awarded the contract to package and distribute Phase III clinical trials, previously performed by a competitor. Following successful trials, the product was granted approval by the Food and Drug Administration and EMEA, and then moved into commercialisation.
Exemplary service and manifest expertise throughout the clinical trials persuaded the client to select Sharp as the service provider for the commercial work.
Exemplary service and manifest expertise throughout the clinical trials persuaded the client to select Sharp as the service provider for the commercial work. The project scope included labelling and kit assembly in two parts: a drug substance and a medical device delivery kit.
Sharp have expanded their current packaging and warehouse facilities by 22% to meet the demands of the work, establishing a segregated commercial packaging facility and a dedicated team to work alongside their current clinical trial business. Sharp has also sought new accreditations to meet regulatory requirements.
The refurbishment and fit out of the facility was completed in May 2015, with validation of packaging activities completed later that month. Two batches of the product have been run, with the first order delivered to the client in October 2015.
Extensive planning and careful execution ensured full compliance with the customer’s timeline and quality requirements.