Audits and PAI Readiness Capabilities

Our Audit Team consists of certified auditors and seasoned Subject Matter Experts (SMEs) across a wide variety of disciplines with extensive expertise in preparing our clients for regulatory body inspections, performing internal audits, external audits, gap assessments, and due diligence evaluations. We manage and execute Chemistry, Manufacturing, and Controls (CMC), clinical, laboratory, and supply chain audits around the world, including support for Pre-Approval Inspection (PAI) readiness.
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Expert Audit Support

Our Current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) audits support the full product life cycle from raw material to finished product to patient use. We have experience with novel, high-risk, complex products (e.g., biologic with multi-use auto-injector). Kymanox provides detailed, timely documentation and personalized support utilizing a risk-based approach. Kymanox is committed to following up on all audit findings and addressing all corrective actions — including best-in-class recommendations for remedy — with the audit sponsor and auditee.
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Pre-Approval Inspection Support

Kymanox has assisted our clients with 19 successful Pre-Approval Inspections (PAIs). Our quality team can prepare our clients for success by assessing process gaps and creating remediation plans, implementing training programs to prepare for inspection, setting up and streamlining the backroom and inspection room, creating storyboards for challenging topics, conducting a mock PAI and delivering a comprehensive report detailing findings, facilitating communication with regulatory agencies, and providing on-site support during a PAI.
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Other Areas of Expertise

Kymanox has conducted many different types of audits including routine maintenance audits, internal audits, mock biannual inspections, and supplier qualifications.
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Quality Assurance, Compliance, & Auditing Difference

Our CGMP, GCP, and GLP audits support the full product life cycle from raw material to finished product to patient use.
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Experience + Approach

We have experience with novel, high-risk, complex products (e.g., biologic with multi-use auto-injector). This experience informs our risk-based approach to personalized support.
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Flexibility & Agility

At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
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Best-in-Class Output

Kymanox is committed to following up on all audit findings and addressing all corrective actions — including best-in-class recommendations for remedy — with the audit sponsor and auditee.
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Frequently Asked Quality Assurance, Compliance & Auditing Questions (FAQs)

My company is preparing to launch a new product to market. Do I need a Mock Pre-Approval Inspection (PAI)?
Mock PAIs are highly encouraged for companies preparing to introduce new products to market. With our highly skilled workforce, subject matter experts will perform a thorough review of production controls, quality management systems, materials management, and laboratory practices in accordance with applicable regulations and in conformance to product filings. Our mission is to identify deficiencies and aid in implementing solutions to ensure your product is approved commercially.  Kymanox takes pride in our PAI track record; we've executed 15 successful pre-approval inspections with FDA approval granted post-inspection. 
What standards do you follow when conducting audits?
Kymanox follows industry best practices in audit execution consistent with the American Society for Quality’s (ASQ’s) approach to quality auditing.  Our team has created SOPs and procedures, including toolkits and checklists that provide everything needed for the auditing process. 
How can we mitigate risks with on-site visits for our third-party vendors when travel conditions are suboptimal?
Kymanox offers virtual audits! We're able to reduce risk and continue quality oversight of your GxP service providers remotely. Virtual tours may be conducted of manufacturing areas, testing laboratories, and warehousing/distribution sites.  Through our online interface, we're able to conduct personnel interviews and review documentation. Our clients are even able to participate in our virtual audits by simply logging in to our online meeting platform.