Quality Assurance, Compliance & Auditing Capabilities
Certified auditors and seasoned subject matter experts (SMEs) with extensive expertise in preparing clients for audits, regulatory body inspections, and other evaluations.
01
Expert Audit Support
Extensive experience with Pre-Approval Inspection (PAI) readiness, mock inspections, supplier qualification (e.g., raw materials, warehouse, manufacturing, laboratories, distribution/3PL), and gap assessments.
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02
Best Practices in Quality Management
Kymanox excels in building fit-for-purpose Quality Management Systems that are phase appropriate. We can help your company implement and maintain systems critical to your product and process.
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03
Areas of Expertise
Corrective and Preventative Actions (CAPA), Change Control, Deviations/Investigations, Design Controls, Risk Management., Complaints/Adverse Events, Document and Records Management., Training, Annual Product Review, Internal Audits, and Supplier Management.
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04
Global Experience
We manage and execute Chemistry and Manufacturing Controls (CMC), clinical, laboratory, and supply chain audits around the world, including support for Pre-Approval Inspection (PAI) readiness.
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Meet our Quality Assurance, Compliance & Auditing Experts
Nathan Blazei, RAC, ASQ-CQA
SENIOR DIRECTOR, REGULATORY AFFAIRS
Markets That Benefit from Our Quality Assurance, Compliance & Auditing Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
The Kymanox 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.
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.
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.
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.
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.
Read the Latest at Kymanox
The Factor Podcast: Navigating the Real-World Environment of Medical Products
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into hea...
The Factor Podcast: Factors to Consider in Support of Clinical Readiness
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of har...
The Factor Podcast: The Role of Human Factors in Medical Product Development
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Shannon Hoste and Rita Lin delve into the importance of real-world evidence, collaboration, and education within the medical device and combinatio...