Dedicated Quality & Compliance Officer to Scale Your Operations Without Adding Overhead
Five Rivers RX has helped many businesses through all aspects of outsources quality and compliance. We utilize internal and external consultants to ensure that your operational practices do not leave any liability. Feel confident in your expanding portfolio by relying on our knowledge, experience, and expertise.
Through our outsourced Quality & Compliance Officer services, clients have access to subject matter experts specializing in FDA quality requirements and unlimited support. This service is designed to help you scale your operations and to stay compliant without adding overhead.
SOP Management: Five Rivers RX handles the headache of SOP revisions and change control to meet client and GMP standards.
CMO Management: Spanning aspects such as Quality Agreement review, due-diligence, CAPA audits and more, we can manage your relationship with your CMOs.
Training: Our team of experts reviews training regularly to identify and correct any gaps. On-demand training modules are also available including annual GMP training.
Annual Reporting: Report development, audit, editing and revising are fully managed.
CAPA: We perform a periodic review of CAPA backlog and an analysis for inspection readiness. Our services cover change control and validation, review of contractor and supplier quality agreements, and more.
Adverse Events & Market Complaints: Our dedicated QA officer manages inbound communication and is supported by our subject matter expert and an attorney that specializes in FDA quality requirements.