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

At Kymanox, our solutions are rigorous, our support is endless, and our work is meticulous.

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 human factors engineering, regulatory, compliance, strategy, and project management solutions 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. 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

Drug 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.

Pharmaceuticals

Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.

Medical Devices & Other

Our diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands.

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 Cares

Giving back in a way that reflects our commitment to enhancing lives

Discover More
Kymanox Careers

Join Kymanox to accelerate your career by helping our clients Get More Done

See Positions