Pharmaceutical Regulation Suites

Overview

The Pharmaceutical Regulation Suite™ and the European Pharmaceutical Regulation Suite™ are the ultimate research tools for finding answers to pharmaceutical compliance questions in the US and the EU. They provide, in a central location, thousands of documents from dozens of entities, many not otherwise available without hours of work or months of waiting for responses to FOI requests.

Get the product brief for the Pharmarceutical Regulation Suite™

Learn more about the European Pharmarceutical Regulation Suite™

Collections on Pharmaceutical Regulation Suite

• Legislation - U.S. Code and public laws
• Code of Federal Regulations - updated continuously
• Federal Register - back to 1991
• FDA and NIH Manuals - including some not available on the web
• FDA Guidelines - searchable across FDA Centers
• Advisory Committee Meeting Transcripts
• ANDAs and NDAs - Summary Bases of Approval back to 1964
• Warning Letters, 483s, EIRs, Cyber Letters - back to the mid-70's
• Court Cases - back to 1938
• FDA Forms
• FDA Press Releases, FOI Logs and other publications
• Monthly Product Approvals, the "Orange Book" and product data
• OTC Drug Monographs
• OIG and GAO Reports relating to FDA
• HIPAA Compliance Information
• ICD-9 Codes and other reimbursement information
• FTC materials on sales and advertising
• EMEA, Directives and more