Development of Quality Procedures, Document and Record Control, Training, FDA 483 and Warning Letters Remediation, Internal Audit Support, Supplier Audits, Mock FDA and ISO Audits, General Quality System Support.
Confident and Transparent
We can audit your existing quality systems. Using our expertise, we can show the FDA that we understand and have identified quality issues and put plans into place to address them. We’ll identify strategic issues with your current quality systems and come up with a plan moving forward.
If you’re a new client, we can start you on the path. We can pass the audits so there won’t be an issue.
We also assist with the development of quality procedures. Our experience in quality system building allows us to know what works. We also look at your very specific situation and can solve your needs without being burdensome.
Our systems have inherent compliance and best practice efficiency built in.
When a company receives warning letters (483s, etc) – other quality consultants often have a knee-jerk reaction to over promise. Our technicians are experienced enough to create a plan that fixes the problem while also being able to execute it. We have experience on both sides of the audit – both hosting and performing. We’re always using these opportunities as a way to build relationships with the auditor or auditee.
This allows us to put our clients in a place to succeed on their own.