Benefits extend beyond cost savings and address three common pain points:
• Talent shortages: Maintaining compliance amidst increasing regulatory complexity, especially in a global context, requires individuals skilled in risk management and knowledgeable of regulatory and compliance operations; these professionals are in short supply and high demand. Organizations are struggling to increase operational budgets to provide training and to gain access to an extended talent pool.
• Sub-optimal compliance processes: Organizations want to focus on improving and streamlining their compliance processes to make them more predictable; however, continual changes in the regulatory landscape can undermine compliance process investments, leading to sub-optimal and non-compliant processes. This may result in higher compliance costs (i.e., through rework, license suspensions) and poor quality of work.
• Technology infrastructure investments: Organizations are constantly investing technology and related infrastructure to help meet compliance needs. With frequent changes existing regulations, as well as the introduction of new regulations, frequent technology investments are needed to keep pace.
Through continuous improvement efforts, Genedrift has been able to optimize business processes with a world-class delivery team resulting in upwards of 40% savings for our clients. It is imperative that regulatory compliance, performance and data quality are achieved in assurance of compliance with FDA regulations. Genedrift is able to deliver 100% compliance, all throughout. Achieving >99% quality of the submissions we make, we make use of advanced analytics, a pool of internal applications and create customized tools that integrate as a part of the existing business applications and eliminate manual processes.
