We are a Modern Life Sciences Consulting Company that Acts as an Extension of Your Team
The breadth of our experience allows us to tackle any modern medicine development & commercialization challenge
01
Development & Operations
Bring your product to market in a timely fashion
02
Quality, Regulatory, & Compliance
Ensure the safety and compliance of your product
03
Commissioning, Qualification, & Validation
Keep your facilities and equipment running properly
04
Strategy, Planning, & Execution
Value added services that apply across the product lifecycle
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
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics and Cell & Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
More Than Consulting, an Integral Part of Your Team
“Right First Time” Execution
Get results with our branded methodology, Ideal Knowledge TransferTM
Dynamic Project Management
A personalized approach that combines your needs with our proven tools
Flexibility & Agility
Clients tell us our flexibility is a key reason they keep coming back
Proven Broad Expertise
Extensive experience across drug, device, & combo product development
Kymanox Careers
Join Kymanox to accelerate your career by helping our clients Get More Done
See PositionsRead the latest at Kymanox
Kymanox Named as Winner of 2022 Triangle Business Journal Life Sciences Award
Friday, 20 May 2022
Morrisville, North Carolina, USA
Kymanox Corporation (“Kymanox”), a professional services company exclusively serving the Life Science industry, announced today that the company has been honored with a 2022 Triangle Business Jo...
Off-The-Shelf Vs. Novel Devices: Considerations When Selecting A Drug Delivery System
Whether bringing a novel therapy to market or altering current devices for lifecycle management, companies must determine the best selection for administration without effecting drug efficacy, quality, and safety. In this article from Life Science Lead...
Remaining Competitive During Global Supply Disruptions
Supply chain disruptions to electronic components have caused challenges to the production of medical devices. Companies have had to become creative and versatile to deliver high quality products. In this article from Life Science Leader, experts from ...