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
Analytical Techniques For Addressing Viral Vector Purification Challenges
When producing gene therapies, circular plasmids containing therapeutic DNA , an outer capsid shell, and proteins required for virus assembly are inserted into host cells. Manufacturers often face difficulties creating consistency in gene therapy produ...
Rapid Microbiologic Methods Aid In The “Race To Release” Challenges Of Cell And Gene Therapy Manufacturing
Rapid Microbiologic Methods (RMM) is perfectly suited to cell-based manufacturing because it allows scientists to obtain results up to ten times faster than traditional culture-based microbiological analysis techniques and with less produ...
Will The Real Critical Tasks Please Stand Up: How To Develop Your Human Factors Risk Assessment And Evaluate Critical Tasks
Human Factors Engineering (HFE) is a risk-based discipline crucial to validating that a medical product and its user interface is safe and effective for the intended users and use environments. The HFE process aims to optimize the user interface for me...