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
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
-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
Drug, device, and combination products submission services such as NDA, BLA, PMA, 505(b)(2), 510(k), DMF, and MAF including...
-Submission Authoring & Review
-QMS Upgrades & eQMS
Post-marketing surveillance (PMS) and life cycle management activities including Phase IV trials benefit from our expertise in areas such as...
-Complaint Management & Investigations
-Process Verification (CPV) & Surveillance