Trusted Experience
RPI is a referral based business that has successfully helped companies achieve their drug development goals for over 15 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) opened its doors in 1995 to serve the growing needs of small to mid-size pharmaceutical and device companies. RPI has helped companies advance the development and registration of products worldwide including the US, Canada, EU and Japan. With a highly qualified and enthusiastic team of experts, RPI has extensive experience in the preparation of complex submissions and in the management of projects requiring specific expertise.

The company was founded by Donna Kato. Donna has 30 years of experience in the pharmaceutical industry, with the past 25 years in regulatory affairs. The business name reflects the company’s focus on all aspects of Regulatory Affairs for drugs, biologics, devices and combination products in both pre- and post-approval settings.

RPI is an experienced team of regulatory professionals dedicated to helping our clients advance the development and registration of their products with worldwide health authorities. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC, clinical development and electronic publishing.

RPI has successfully helped companies achieve their drug development goals for over 15 years. RPI can provide the services of a fully staffed regulatory department for start-up companies or complement existing resources and reduce the need for investment in permanent hires. RPI has a track record of providing clients with high quality deliverables in a timely manner. Our hands-on approach and accountability allow us to work with clients as part of their trusted team.