Proven Solutions to Help Clients Cross the Finish Line

Kymanox® specializes in making it easy for you to Get More Done!

A Partner Dedicated to Helping You Meet Your Goals

More Than Consultants, Kymanox Is an Extension of Your Team

"Right First Time" Execution

We are 100% focused on the life sciences industry with a team of experts that has extensive experience across drug and device development. In addition to our full time staff, Kymanox has attracted a well-credentialed contractor network that allows us to help clients more effectively with compliance solutions in life sciences.

We help clients globally to accelerate development and delivery of modern medicines. We invite you to look at our Leadership Team to learn a little more about our team.

Meet Kymanox

At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.

How are we able to do this? Our employees & company culture. We find people that obsess over life sciences and then recruit those who are hungry to make a difference in line with the Kymanox Why. Mix in our like-minded contractor network and you have a team that is eager to tackle your development challenge.

Meet Kymanox

We drive projects to the highest level of performance by connecting people to people and people to processes. With Kymanox, you receive a personalized approach to project management that combines your needs with our proven tools and expertise to create a custom solution for your project.

We lead, plan, manage, organize, monitor, and control projects to align with your goals. You can rest easy knowing deliverables will be complete in line with your expectations.

Meet Kymanox

Markets That Benefit From Our Regulatory Affairs Solutions

Biotechnology

In the dynamic realm of biotechnology and cell and gene therapy we continue to offer innovation solutions and guidance

Combination Products

Our experts understand the interaction between devices and drug products and are ready to support your next project

Diagnostics

Our team supports in vitro diagnostic (IVD) medical product development and registration in both the EU and US markets

Medical Devices

Building on over three decades of experience in the medical device industry, Kymanox has been at the forefront of innovation

Pharmaceuticals

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

Frequently Asked Regulatory Affairs Questions (FAQs)

With which regulatory filings can Kymanox assist?
Kymanox interacts on behalf of our clients with regulatory bodies and health authorities to lead various filing activities (e.g., IDE, PMA, IND, NDA, BLA) and to lead negotiations that resolve issues and respond effectively to 483s, Warning Letters, Consent Decrees, and Complete Response Letters. 
Can Kymanox help with my pharmaceutical/combination product development and regulatory strategy?
Yes, Kymanox’s expert staff of pharmaceutical development scientists and drug delivery device engineers can provide a breadth of strategic development and regulatory planning services throughout the stages of clinical development and up to market authorization.  Kymanox is well versed in navigating the complexities of product development to deliver and maximize the potential for commercial success.  These services include, but are not limited to, the evaluation of formulation technologies and selection and optimization of drug product formulation; evaluation of manufacturing process technologies, process development, scale-up, and technology transfer; analytical and microbiological method development and validation support; technical writing of protocols and reports; evaluation, selection, and optimization primary packaging components and drug delivery systems; stability study strategy and design; and the evaluation and selection of contract organizations. 
Can Kymanox author CMC (Quality) Sections of my IND, NDA, ANDA, or BLA?
Kymanox has an expert staff of regulatory and technical writers who are intimately familiar with authoring the CMC (Quality) sections for all submission types.  Kymanox is also well versed in preparing all sections of your submission, as well as Briefing Packages to support communications from Pre-IND through Pre-NDA/BLA. 
Can Kymanox handle regulatory submissions outside the U.S.?
Yesthe Kymanox team is experienced with the regional regulatory requirements and expectations for submissions to EU, Japan, Brazil, and Canada.