Regulatory Professionals, Inc.

Providing Strategic and Tactical Regulatory Services

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▼ 2017 (2)
- ▼ January (2)
  - FDA Data Standards Implementation Deadlines
  - Submission of Manufacturing Establishment Information

Regulatory Professionals, Inc.: Welcome to Regulatory Professionals, Inc. (RPI). My name is Donna Kato and I am President of RPI. Thank you for visiting my online diary. I have 30 years of experience in the pharmaceutical industry, with the past 28 years in regulatory affairs for drugs, biologics, gene therapy and drug/device combinations. RPI is a consulting firm based in the San Francisco Bay Area that provides regulatory expertise to the pharmaceutical and medical device industry. RPI has grown over the years to include clients across the US, Canada, Europe and Japan. The business name reflects the company's focus on all aspects of Regulatory Affairs including preclinical, CMC and clinical support for pre- and post-approval products. Additional services include Medical Writing, Project management, Quality Assurance (QA) and Drug Safety. RPI has decades of experience with every Division at FDA and on projects covering many therapeutic areas. RPI's track record of regulatory approvals is second to none.

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