We Are Your Life Science Solutions Partner

Kymanox is a premier professional services organization with a focus on project delivery. Our team of experts provides life sciences clients with engineering, scientific, quality, and regulatory support. Leveraging our Kymanox Project Management Toolkit, our people and tools are tuned for commercializing late-stage development programs in biotechnology, pharmaceuticals, medical devices, and combination products.

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Our Ideal Knowledge Transfer™ (IKT™) helps organizations achieve predictable project success
Develop and maintain Project Management Office (PMO) policies, procedures, and templates
Advanced reporting tools communicate scope, schedule, budget, and risk to ensure projects stay on track (e.g., project dashboards, KPIs)
Execution-focused methodology
Planning and risk management employed early to avoid costly and often irreversible missteps
Working meetings have pre-published agendas, detailed meeting minutes, and tracked action items and decisions

Process Engineering, Manufacturing Science, Technical Services, Analytical Sciences, and Product Development
Industry leading Tech Transfer Toolkit™ reliably links Development and Manufacturing
Aligned with principles of Quality by Design (QbD) and integration of professional project management methodologies
360° view and orthogonal approach: - Process-Centric - Statistics and Data Analytics - Proactive Measures and Remediation - Full Lifecycle Management - Training

CGMP Commissioning, Qualification, and Validation (CQV) leveraging requirements documentation and risk management
Proven past performance includes facilities, utilities, equipment, Computer System Validation (CSV)/Part 11, methods, processes, and cleaning
Best-in-class documents stand as monuments for compliance and your business
Extensive design experience means we understand what we are validating
Specialty CSV and Part 11 compliance for Enterprise Resource Planning (ERP) systems (e.g., SAP)

Our experts eliminate ambiguity surrounding regulations and published guidance to make end requirements clear and concise
Quality and Regulatory support for biotech, pharma, medical device, in vitro diagnostic devices (IVD), and combination products
Regulatory submission project management, authoring, and review
Turnkey Pre-Approval Inspection (PAI) readiness
Full Quality Management System (QMS) development and implementation
Regulatory body responses and remediation
Audit program oversight and execution
Quality engineering support for medical devices and combination products

Kymanox promises to help you Get More Done.

Simply put, we help bring modern medicine from bench to patient.

Partner with us today to Get More Done.

Solutions

Our solutions are limitless. We invite you to review our offerings and see how we may partner together to get more done.

Nathan Blazei Joins Kymanox as Head of Quality

30Mar2021

On Demand – Lessons from Inspiring Women Life Science Leaders: A panel discussion to celebrate International Women’s Day

11Mar2021

Lessons from Inspiring Women Life Science Leaders: A panel discussion to celebrate International Women’s Day

11Feb2021

How the FDA Defines Combination Products

05Feb2021