Inefficient or inadequate processes within postmarket surveillance programs can lead to large complaint file backlogs and other problems that put FDA-regulated manufacturers and patients at risk. Whether due to internal resource constraints, systems issues, or any other deficiency, manufacturers face severe regulatory repercussions when product issues are not addressed in a timely and compliant manner. Correcting and preventing these problems requires thorough evaluation to reveal system gaps followed by a remediation program to ensure systems operate efficiently and in full compliance well into the future.
Our experienced postmarket surveillance experts begin by reviewing an existing gap assessment or performing systems audits and analyzing a statistical sample of your backlog and other impacted areas. This advanced sampling technique reveals the true magnitude of the problem, enabling you to see the full picture of the issue and prioritize actions.
Following this comprehensive assessment, our experts review all internal processes and procedures currently used to handle these issues and develop sustainable improvements that not only remediate deficiencies, but make the enhancements necessary to be efficient and compliant in both today and tomorrow’s regulatory environment. Our staff can also augment your internal resources to remedy existing file backlogs as quickly as possible.
We recognize the challenges of developing and managing an effective postmarket surveillance program under the watchful eye of regulators in a quickly-changing landscape. Our professionals draw on years of experience, highly specialized skills, and best practices developed through work in the field to ensure objective, accurate, and actionable recommendations are made each step of the way.
Our proprietary talent selection process brings together a diverse array of skill sets, experience, and expertise to offer a truly unique opportunity for companies interested in receiving personal and professional attention.