A Compliance Audit Can Protect Your Business & Patients.
Compliance regulations can be overwhelming for any pharmaceutical manufacturer or FDA-regulated facility. Non-compliance can mean big fines, product recalls, and reputation damage. We understand these challenges and offer full compliance audits to help you meet and beat the regulations.
With expert compliance auditing, we will review your internal business processes and ensure your operations are FDA-compliant. Our services are designed to protect your investment and improve the quality of your products so you can maintain regulatory compliance and stay ahead of the competition.
Assessing Each Compliance Regulation to Keep Your Facility in the Clear
Amicus offers a range of compliance audits to suit your needs, including GMP Six System Audits, Contract Testing Laboratory Oversight & Qualification, Due Diligence Audits, Remote & Virtual Inspections, and Vendor & Supplier Audits. We will give you actionable insights and a clear path to improvement so that you can establish solid internal guidelines and avoid negative action from the FDA.
GMP Six System Audit: Uncover any weaknesses in your regulatory compliance processes.
Contract Testing Laboratory Oversight & Qualification: Verify that your testing labs meet client and FDA standards.
Due Diligence Audits: Vet potential partners or acquisitions.
Remote & Virtual Inspections: Stay compliant with minimal disruption.
Vendor & Supplier Audits: Ensure your entire supply chain adheres to regulatory guidelines.
The Compliance Audit Process
Initial Consultation
Customized Audit Plan
Audit
Audit Report
Implementation Support
Follow-Up Audits
Frequently Asked Questions
We perform GMP Six System Audits, Contract Testing Laboratory Oversight & Qualification, Due Diligence Audits, Remote & Virtual Inspections, and Vendor & Supplier Audits.
Amicus will provide internal audits and readiness assessments to help your facility meet compliance requirements and avoid FDA scrutiny and penalties.
We service companies in FDA-regulated industries, including 503b outsourcing facilities, pharmaceutical manufacturing companies, and medical device companies.
In most cases, your external compliance auditor will be hands-off after handing you an audit report. We work to identify problems and support you in implementing solutions by combining deep industry knowledge with a hands-on approach. We can work with large or small budgets to deliver client-specific solutions that drive compliance and business success.
Yes, we offer remote and virtual inspections so you can identify your weak spots and implement solutions with minimal disruption.
Get in Touch!
Partner with Amicus to achieve the highest standards of regulatory compliance and patient safety. Our expert compliance auditors are ready to provide you with the insights and support you need to face the complexities of FDA regulations.
Reach out to get started!
