Quality System Remediation
The Premier FDA Solutions Difference: Identifying issues. Executing a plan. Preventing recurrence. In this highly regulated industry, managing the everyday manufacturing process can be difficult enough, and companies may not have the resources to properly address quality management system (QMS) issues. We have a large network of quality and compliance experts with the knowledge and experience to identify the root cause of those issues and develop a plan to remediate them – and keep them from recurring.
Remediation Services with Scalable Flexibility
Whether you need one consultant to assist with determining the best approach, or several to work with your team on executing a remediation plan, we can tailor the solution to fit the unique needs of your project.
Proactive Quality System Management
Surviving an inspection is all about managing risk – and knowing what is important to the FDA. What’s important to the FDA is a solid quality management system and documentation, and our quality and compliance experts can help you proactively develop and implement a quality management system that will withstand the closest scrutiny.
The Premier FDA Solutions Difference: We understand that FDA regulatory compliance is but one component of the complex set of regulations impacting Compliance Services for Life Sciences business. Here are some of the key components of our approach to FDA Compliance Services:
- We’ve made the life sciences our sole focus – because the life sciences are incredible.
- We offer flexible staffing solutions so you get the expertise you need when you need it – because compliance is not one-size-fits-all.
- We’re always curating our network of regulatory and quality experts – because integrity matters.
- We advise clients on the design and implementation of compliance programs that address fraud and abuse, labeling and promotion, and various reporting obligations.
- We guide and assist clients through complex internal investigations as well as responding to government enforcement actions related to life sciences regulations, including compliance with the anti-kickback statute, transparency reporting, clinical trial compliance, and privacy.
- We find contract resources for projects for “Right-Sized” Outsourced Staffing and Staff Augmentation & Recruitment (see below).