One Direction.
One Goal.

we are

Utilizing the 505(b)(2) pathway.

Our Transdermal Innovative Products are the result of scientific expertise and unrelenting effort. We have chosen the 505(b)(2) regulatory pathway to maximize the potential of proven oral medicines.

By taking advantage of a large predefined, predictable market, with the shortest path to regulatory approval, we are able to forge a niche that offers both exclusivity, and branded products. The route to success is unambiguous. The 505(b)(2) pathway follows a strategic decision that produces results, avoids untimely delays, and delivers a product that is ready for license:

Identify Products with Meaningful Potential

Formulation Development

Skin Permeation / Dissolution Studies

Scale Up Studies

Conduct Clinical Trials with CRO Partner

Prepare Product for Regulatory Submission

License Product

Our strong product pipeline is already populous and continues to expand rapidly.   Spanning a wide spectrum of indications, each product is focused on utilizing the 505(b)2 regulatory pathway in order to get to market quickly, precisely, and smoothly.

As a result we impact patients' lives with innovative medicines.

Are you ready to learn more?