Life Science Solutions

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

Start Getting More Done

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Development & Operations

Bring your product to market in a timely fashion

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Quality, Regulatory, & Compliance Solutions

Ensure the safety and compliance of your product

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Commissioning, Qualification, & Validation

Keep your facilities and equipment running properly

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Strategy, Planning, & Execution

Value added services that apply across the product lifecycle

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Strategy, Planning, & Execution

Supporting You Through Every Stage of Development

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

Work With Kymanox

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!