Regulatory Professionals, Inc.

	Trusted Experience RPI is a referral based business that has successfully helped companies achieve their drug development goals for over 12 years.
	Customized Approach With a thorough knowledge of the regulatory environment, RPI offers creative approaches to working effectively with FDA and other regulatory agencies.
	Optimize Resources RPI can complement existing resources and reduce the need for investment in permanent hires.
	Maximize Value The result is expedited drug development time and reduced overall cost.

Regulatory Professionals, Inc. (RPI) is a consulting firm providing regulatory expertise to the pharmaceutical and medical device industry.

Headquartered in the San Francisco Bay Area, RPI offers strategic and tactical regulatory services in accordance with FDA/ICH standards for small to mid-sized companies in all phases of drug development. RPI provides a wide range of support levels to supplement existing scientific and regulatory staff. RPI can act as a start-up company's head of regulatory affairs, assisting with presentations to the Board of Directors, investors and FDA or foreign equivalent. RPI can support larger projects such as marketing applications, or provide as-needed assistance during times of high demand.

"It continues to be a pleasure working with RPI. Donna Kato has made the occasional rough regulatory ride advance smoothly and seamlessly AND this is always absent getting the organization into a "tizzy". She is a real pro."
  Michael S. Perry, DVM, PhD
  Chief Development Officer, VIA Pharmaceuticals, Inc.
  Venture Partner, Bay City Capital

"Donna and her team provided strategic and tactical guidance for our NDA submission, which was completed in a timely fashion. We couldn 't have done it without them."
  Peter Tam
  Sr. Vice President, Product Development, VIVUS, Inc.


U.S. Food and Drug Administration	European Medicines Agency	ICH	Health Canada