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 Solutions
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
Why Choose Kymanox?
Our leadership includes previous FDA human factors leadership, entrepreneurs, inventors, and talented engineers to ensure your products have commercial success.
If you're searching for life science solutions you can rely on, look no further than Kymanox. We are a modern life sciences consulting company, and our goal is to accelerate your modern medicine delivery.
Whether you're a pharmaceutical company or a biologics company, we've got you covered. Kymanox provides comprehensive life science solutions that include human factors engineering, regulatory, compliance, and strategy to advance treatments from bench to patient. With our experience and knowledge, our diverse team of experts is ready to offer support from early development to post-market products.
At Kymanox, we value the tireless work that you do to create medical products that better the lives of countless individuals, and we’re passionate about providing the life science solutions that you need to complete projects efficiently and in a timely manner. No matter what type of product you’re developing, our life science consulting services will help you streamline the entire process. Our expert team will ensure safety, efficiency, and strong communication every step of the way. Our prioritization of Ideal Knowledge Transfer™ (IKT) enables us to provide the highest quality of service when it comes to helping you achieve your goals.
Don't trust just anyone when it comes to developing modern medicines. Turn to Kymanox for your one-stop solution. Have questions about the services we offer? Give us a call today!
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 & Cell and 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
The Factor Podcast: Navigating the Real-World Environment of Medical Products
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into hea...
The Factor Podcast: Factors to Consider in Support of Clinical Readiness
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of har...
The Factor Podcast: The Role of Human Factors in Medical Product Development
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Shannon Hoste and Rita Lin delve into the importance of real-world evidence, collaboration, and education within the medical device and combinatio...
