We are a Modern Life Sciences Consulting Company that Acts as an Extension of Your Team
Development & Operations
Quality, Regulatory, & Compliance
Commissioning, Qualification, & Validation
Strategy, Planning, & Execution
Supporting You Through Every Stage of Development
Early Development
From pilot studies or preclinical studies to Phase IIb, Kymanox provides many services helpful for programs in the early stages of development such as...
-Human Factors Strategy
-Project Management
-IND Authoring & Submission
Late Stage Development
Phase III clincial studies and other later stage development activities can benefit from our technical and compliance solutions including...
-PAI Readiness Planning
-Scale Up and Tech Transfer
-Control Strategy
Commercialization
Drug, device, and combination products submission services such as NDA, BLA, PMA, 505(b)(2), 510(k), DMF, and MAF including...
-Submission Authoring & Review
-Launch Preparation
-QMS Upgrades & eQMS
Post-Market
Post-marketing surveillance (PMS) and life cycle management activities including Phase IV trials benefit from our expertise in areas such as...
-Complaint Management & Investigations
-Inspection Remediation
-Process Verification (CPV) & Surveillance
Markets That Benefit from Our Solutions
More Than Consulting, an Integral Part of Your Team
“Right First Time” Execution
Dynamic Project Management
Flexibility & Agility
Proven Broad Expertise
Join Kymanox to accelerate your career by helping our clients Get More Done
See PositionsRead the latest at Kymanox
Nathan Blazei Joins Kymanox as Head of Quality
On Demand Webinar: Lessons from Inspiring Women Science Leaders for International Women’s Day
