Raleigh-Durham, North Carolina; King of Prussia, Pennsylvania, USA; Bern, Switzerland, Aug. 06, 2026 (GLOBE NEWSWIRE) — Kymanox®, a global life science professional services and consulting firm supporting the development and commercialization of modern medicines, announced the launch of its proprietary AI-enabled solutions for pharmaceutical, biotechnology, medical device, and combination product companies. At the core of these capabilities is the Kymanox Artificial Intelligence (KAI) Engine, purpose-built for regulated work and designed to apply the right AI capability to each task, with qualified Kymanox experts verifying every output. By pairing Kymanox’s deep domain expertise with task-specific AI workflows, Kymanox helps life science organizations complete high-quality, compliant work faster while maintaining the rigor that regulated industries demand.
Kymanox is initially applying these capabilities to three high-impact quality and regulatory service areas, where clients face time-intensive, high-volume documentation demands, requiring both efficiency and expert oversight.
- QMS Development and Enhancements. Powered by the KAI Engine, this service assists in drafting documents, conducting gap analyses, and harmonizing the QMS documentation, enabling clients to stand up or strengthen a right-sized, audit-ready QMS in a fraction of the traditional time.
- Batch Release Report Review. Powered by the KAI Engine, the solution includes an intelligent review of paper-based batch records and associated release documentation to identify documentation discrepancies, data integrity concerns, and potential deviations to support batch disposition, improving both speed, quality, and consistency of release decisions.
- Human Factors Study Optimization. In partnership with Sanai, a global leader in advanced artificial intelligence specifically focused on the pharmaceutical and biotechnology industries, this Human Factors AI offering runs on Sanai’s proprietary platform, customized and deployed for Kymanox. It automates the aggregation, review, and summarization of human factors study data, accelerating usability analysis and regulatory-ready reporting for combination products and medical devices.
Responsible AI, By Design
Kymanox has built its AI capabilities around a simple principle: AI accelerates the work; experts own the outcome. Every AI-assisted deliverable is reviewed and verified by qualified Kymanox subject matter experts before it reaches a client. Expert-supervised AI is paramount to ensure effective implementation and quality deliverables. The company’s responsible AI framework emphasizes human-in-the-loop oversight, transparency into how AI is used on each engagement, documented workflows aligned with GxP expectations, and continuous monitoring of AI performance and accuracy. The solutions were developed by the Kymanox AI Center of Excellence, established in 2024 to assess both internal and external AI opportunities and determine the best path forward for meaningful offerings that support Kymanox professionals and clients.
“My number one rule when using AI is that it should not do the work for you; it should work with you,” said David Dlugo, Senior Director of Quality of Kymanox. “We are adopting these initial capabilities deliberately, so our clients can accelerate innovation and outcomes with the highest level of quality and compliance.”
Client Data Security and Privacy
Recognizing that clients entrust Kymanox with highly sensitive intellectual property and regulated data, the AI capabilities operate within a secure environment designed to protect confidentiality with enterprise-grade encryption, strict role-based access controls, and full data segregation between clients. Client data is never used to train AI models, and all AI-assisted workflows adhere to Kymanox’s confidentiality obligations, data integrity principles (ALCOA+), and applicable data protection regulations.
“Our clients need trusted partners who can deliver quality outcomes faster. Responsible AI has become a real differentiator in our industry. Both our clients and regulators, including the FDA, now expect evidence that AI is governed, not just deployed, and that’s what we deliver,” said Evan Edwards, Chief Executive Officer of Kymanox. “By embedding these AI capabilities into our proven quality and compliance services, with our experts verifying every output, we’re giving clients the best of both worlds: the speed of modern technology and the judgment of seasoned professionals.”
Sanai takes this same approach to responsible AI use and security. “Sanai was founded to automate the data analysis and documentation deliverables behind drug and device development, using robust human-in-the-loop verification. Initially deployed within Top-20 pharma, our platform was built to meet the highest levels of compliance, and we are proud to bring that same standard of excellence to Kymanox and the clients they serve,” said John Walters, CEO of Sanai.
These AI-enabled capabilities are available now to clients who approve the use of Kymanox AI solutions as part of an engagement with the Company. Kymanox plans to expand its AI-enabled and expert-verified service areas throughout the latter part of 2026 and into 2027. To learn more, visit https://www.kymanox.com/kymanox-artificial-intelligence-solutions/
About Kymanox:
Kymanox® is a global life science professional services and consulting firm dedicated to accelerating the development and delivery of modern medicines. We provide proven, end-to-end solutions that help bring life science products to market – and keep them there. Our global team supports clients in Design, Development & Testing; Quality & Compliance; Biologics & Advanced Therapies; Combination Products; and Facilities & Manufacturing Services. From pre-clinical to post-market, Kymanox mitigates challenges, ensures readiness, and advances innovation…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm.
About Sanai:
Sanai Inc. is a global leader in advanced artificial intelligence focused on the pharmaceutical and biotechnology industries, transforming how life sciences companies accelerate drug development, reduce costs, and maximize R&D returns. Sanai’s platform spans IND/IDE submissions, clinical trials, and regulatory approval, transforming raw data into regulatory and compliance documentation workflows, unified in one intelligent platform. With a team of experienced drug and device developers and skilled AI engineers, Sanai is the partner of choice in shaping the AI future of life sciences organizations. For more information, visit https://sanai.ai/
For additional information or interview requests, please contact the media team at the information below. Visit https://www.kymanox.com/contact/ to get in touch.
Expert supervised AI
Press Inquiries
Media Contact:
Michelle Frakes, PhD
Vice President, Business Solutions & Marketing
Kymanox
michelle.frakes@kymanox.com
