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MediRegs Pharmaceutical Regulation Suite

The ultimate tool for research on pharmaceutical compliance guidance and regulations.

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MediRegs Pharmaceutical Regulation Suite is the most robust resource for finding answers to pharmaceutical compliance questions in the United States. Keep up with the FDA’s approval and enforcement activities in connection with thousands of drugs, biological products, and relevant companies using this powerful tool.

Quick searches for critical information make it easy to get all the information required for compliance-readiness using a single, robust search tool. Stay connected to key regulatory information with extensive archives and automatic daily updates. Bookmark, make personalized notes, and share any document via email or save to multiple formats.

What’s New Email Alerts keep you informed and up-to-date on developments in the industry:

  • Daily What’s New—Highlights new  content that was added each day
  • Week In Review—Summarizes and links to important content and updates for the week
  • Personalized Alerts—Delivers new documents matching your stored searches


Easy access to thousands of compliance documents, rules and industry resources

With MediRegs Pharmaceutical Regulation Suite, you have instant access to an  unparalleled spectrum of documents from government agencies, including thousands otherwise available only through painstaking and protracted Freedom of Information requests.

  • Code of Federal Regulations, including 21 CFR and thirteen other titles other titles, updated continuously
  • Federal Register, updated daily, with archives back to 1991
  • U.S. Code and public laws
  • Import Alerts in a table sortable by date, alert number or title/description
  • CDER monthly generic drug approvals and Orange Book
  • FDA Freedom of Information (FOI) Logs
  • Press releases, speeches, testimonies and forms
  • Safety information and drug safety labeling changes
  • FDA manuals and guidance documents, including the CDER guidance database
  • Warning and cyber letters and CDER untitled letters to pharmaceutical companies
  • Enforcement reports and court cases
  • Many other important documents and resources
Training & Support

Wolters Kluwer offers a full range of training; from online videos to custom training.

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