Outwater Regulatory Consulting, LLC

About ORC

Outwater Regulatory Consulting, LLC is owned and managed by Robert I. Outwater, a seasoned regulatory professional with over 30 years experience in the pharmaceutical industry.   The "value added" in selecting Outwater Regulatory Consulting is simple: experience, experience, experience. The company is largely focused on strategic regulatory matters. This focus takes advantage of the extensive experience base, enabling clients to achieve the maximum value for their consulting budget.

Outwater Regulatory Consulting is supporting both U.S. and International clients. 


Biographical  Information-Robert I. Outwater

Outwater Regulatory Consulting, LLC (2007-present) 

OraPharma, Inc (a Johnson & Johnson company)-Vice President Regulatory Affairs, Board Member, Health Care Compliance (HCC) Officer-multiple international drug approvals and development of firm’s HCC program


Hurley Consulting Associates, Ltd.-Vice President Operations-Senior regulatory advisor for multiple US and international clients and senior member of management team


Ohmeda Pharmaceutical Products Division Inc.-Senior Director Worldwide Regulatory Affairs-Directed all regulatory matters and established new international office and new CMC functions 


Pharmaceuticals Division, CIBA-GEIGY Corporation-Director Cardiovascular Regulatory Affairs- Responsible for US portfolio of all investigational and marketed cardiovascular products including successful development and approval of multiple drugs (eg. Lotensin)-Other positions held at CIBA-GEIGY:  Scientist in pharmacology and regulatory positions of increasing responsibility