Regulatory Strategy

Our innovation stems from looking carefully at compounds which have been ignored as possibilities by applying creative processes to the nature of the condition they treat and how they can be optimally delivered.

We aim to acquire, license or co-promote already approved products which fit our channel strategy - targeting serious conditions that require hospital care. Our initial focus is on oncology/supportive care. In addition, we plan to reformulate compounds which have not been optimized for use as ready-to-use oral liquids. Our regulatory networks are broad and deep. We aim to use low cost, low risk 505(b)2 approaches and also focus on Orphan Drug possibilities.

The 505(b)(2) process relies in part on the FDA's review of previously approved pharmaceutical products. This approach can significantly reduce the regulatory and clinical process time to IND approval by years, with similar reductions in the overall cost of development. Successfully securing Orphan Drug status confers many benefits to the company, but more importantly, creates treatment options for patients who would otherwise have none.

PediatRx will use its Scientific advisors and other industry experts in formulation, drug development and 505(b)(2) and Orphan Drug applications.

This unique approach strongly positions us as a valuable partner for companies who wish to create access for their products in the hospital and pediatric pharmaceutical sectors.