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
|