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 Mgmt., Complaints/Adverse Events, Document and Records Mgmt., Training, Annual Product Review, Internal Audits, and Supplier Mgmt.
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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
HEAD OF QUALITY
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
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
Nathan Blazei Joins Kymanox as Head of Quality
Kymanox, a full-service life sciences solutions provider supporting commercialization of vital medicines and treatments, is proud to announce the addition of Nathan Blazei as Head of Quality. This new role will allow Kymanox to further enhance quality,...
On Demand Webinar: Lessons from Inspiring Women Science Leaders for International Women’s Day
"As women, our ability to pivot and persevere when our lives become disrupted has become a leadership advantage!" ~Jennifer Johns
https://kymanox.canto.com/direct/video/lfjpc5oos96hjeis95ger0ib6u/COge77h8J0ePzIoIvDXSggh3J_w/original?conte...
How the FDA Defines Combination Products
Is your product a combination product? Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products. The FDA identifie...