At EnDev, our job is to create “what’s next” in the world of therapeutic skin care and prescription dermatological products.We use our collective experience and expertise, along with a willingness to embrace the unconventional, to follow the science until it takes us where we want to go.
When it comes to new product formulation, there are no cookie-cutter solutions. It requires creative thinking, a mastery of scientific principles, and the ability to never take no for an answer. That’s how new products are born, and why we’re able to so successfully transform our clients’ ideas into the products they envision.
While we have very deep experience in dermatological product development, our core skill is partnering with you to bring your idea or product to life. To accomplish this, we combine the following services with effective project management:
Formulation and Process Development
The gap between an idea and its execution doesn’t care about anyone’s pedigree. Nowhere is this more apparent than in the development of a formulation. That’s why we use a multidisciplinary approach that is broader than industry standard. This makes us good with unusual problems, which is important, because when you work in the gap between concept and reality, you don’t always get to know what kind of problem you are facing until you are in the middle of it.
What do we know? How do we know it? How well do we know it? These questions are the foundation of our analytical services and why we say, we are scientists doing drug development rather than drug developers who have borrowed the tools of science.
We have a full complement of analytical methods and tools in place, but our rigorous, multidisciplinary approach also gives us the ability to handle very complex and unusual problems. When trying to bridge the gap between the actual and the possible, you can never be too accurate or too right.
We work hard, in a smart and efficient manner to help you realize the maximum value when outsourcing. We ensure a seamless transfer of internally or externally developed products into our manufacturing facility. By incorporating Design of Expermiment (DOE) methodologies, Quality by Design (QbD) principles, and Technical Risk Assessment (TRA) strategies, typical transfer challenges are managed proactively and the result is a robust and efficient manufacturing process.
Regulatory approval is part art, part science and a dash of bureaucratic know-how. Helping your product clear this gap, the first time, without retesting or reformulation is our goal. Having helped many clients through this process, we have substantial experience dealing with the FDA. We can handle every aspect of your approval on a turnkey basis, or provide you with the timely analytical information required to handle it yourself.
Endev is a new venture of Ei, a full-service CMO. This not only grounds us in the realities of manufacturing, but allows us to provide you seamless options for moving to commercialization.
150 N. Research Campus Dr.
Kannapolis, NC 28081
Phone: (704) 939-4329