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Regulatory Intelligence

Per the RING (Regulatory Intelligence Network Group) a DIA SIAC, RI is:

“The act of gathering and analyzing publicly available regulatory information.  This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.”

Regulatory intelligence, information and research is our specialty and there doesn’t seem to be a question we can’t find the answer to (yet).  Let us help:

  • Be your Regulatory Intelligence Department

  • Provide precedence research and analysis for a therapeutic indication

  • Conduct research and/or global surveillance, including “Hot Topic” summaries

  • Commenting (anonymous or on behalf of the company)

  • Set up your RI department and/or manage RI information for your company

  • Build a SharePoint site to help manage RI information/intelligence

  • Assist is selecting the appropriate RI tools for your company’s size, needs and budget

  • Write and publish newsletters specific to your company’s needs

  • Conduct comparative RI across the requirements for 75+ countries

  • Construct both Advisory Committee member and FDA Reviewer profiles


At Regulatorium we believe in teaching beginners through experienced RA professionals the basic operational aspects of regulatory that typically can only be learned on the job and through experience. Each publication we produce provides practical information and guidance that can be immediately applied on the job.

Published Books:

A review of IND Submissions: A Primer from the DIA Journal in November 2012

Books to be Bound in 2020

  • FDA Meetings 101

Note: discounts can be offered on bulk or educational orders, please contact publisher or Regulatorium for more information


We have written and published a variety of articles on an array of topics to help with training and teaching the operational aspects of regulatory often only taught on the job. Below is a listing of articles by subject matter.

Regulatory Intelligence

New Drug Application (NDA) and Marketing Application

Regulatory Strategy

Scientific Meetings/FDA Meetings

Expanded Access/Rare Disease/Orphan

Electronic Submission Publishing/21 CFR Part 11

Global Regulatory & Submissions


Safety/Complaint Handling

Combination Devices


Sometimes the hardest part about a job is figuring out how to collect or present the information, so we’ve provided some templates to help you get started on your journey of regulatory intelligence.