SOLUTIONS STABILITY STUDY DESIGN – SME DATA REVIEW

A major provider of solutions based medical devices and drug products sought consulting advice to analyze their existing stability database and prepare stability summary reports in support of several pre-sub 510k submissions. This activity was required to fulfill a commitment made to the FDA. Dellshire expertise ensured the timely preparation of the required stability summary reports in support of several key products. Dellshire consultants provided timely and skillful technical advice, data analysis expertise and technical writing skills in order to ensure the client satisfied their internal and external regulatory commitments within the required schedule.