Intelligence
Publications | Articles | Templates | Worldwide Links
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
Publications
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
Articles
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
2017 Regulatory Intelligence Tools Update: Drugs. Regulatory Focus. March 2017. Regulatory Affairs Professionals Society.
Regulatory Intelligence Tools I Cannot Live Without: Top 5 Free and for a Fee. Focus, March 2012.
Regulatory Intelligence Tools Update 2008: Drugs and Biologics. Focus, August 2008. Pgs 38-45.
Regulatory Intelligence Databases for Drugs, Biologics and Devices: 2007 Update. Focus, December 2007. Pgs. 32-43.
Information Database for Regulatory Intelligence: A Review. Focus, October. Pgs. 34-37.
Regulatory Information for the Small Company: How to Find, Manage and Store it. Focus, July 2003, pgs. 33-35.
Regulatory Intelligence: 2017 FDA Review and Trends to Watch. Regulatory Focus, February 2018.
Regulatory Intelligence Brief: 2017 FDA Overview, Pharmaceutical Manufacturing. 12 December 2017
Regulatory Strategist Toolbox: 2018 FDA Regulatory Intelligence Briefing. Regulatory Focus, May 2019
New Drug Application (NDA) and Marketing Application
The Prescription Drug User Fee Act (PDUFA): A Primer. Regulatory Focus. April 2017.
Planning Regulatory Timelines: Capturing Realistic Approval Timeframes. Focus, October 2006. Pgs 22-27.
Regulatory Strategy
Bridging the Gap: Approvable and Non-Approvable NDAs. Focus, July 2005, pgs. 19-24.
The Regulatory Strategist Toolbox: Clinical Endpoint Analysis Tools. Regulatory Focus, September 2018.
Scientific Meetings/FDA Meetings
Scientific Advice Meetings with Health Canada, Regulatory Focus. May 2015. Regulatory Affairs Professionals Society.
Expanded Access/Rare Disease/Orphan
Public Availability of Expanded Access Policy: How to Comply With new Requirements. Regulatory Focus, April 2018.
Regulatory Strategist’s Toolbox: Global Orphan Drug Regulations, Requirements and Designation Requests. Regulatory Focus, August 2018.
Orphan Drugs Around the World: The Regulations and Requirements You Need to Know. RAPS, 17 September 2014.
Electronic Submission Publishing/21 CFR Part 11
Electronic Regulatory Publishing Software: From the stone age to the space age. Focus, December 2002, pg. 5-10.
Regulatory Publishing. Regulatory Affairs Journal, vol. 13(10), 2002, pg. 821-828.
21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules. RAPS, 6 November 2014
Budgeting for the IND in an eCTD Format: to Insource or Outsource? Regulatory Focus, March 2018.
Electronic Publishing Conversion: A Reference Guide to Converting Paper Submission to eCTD. Regulatory Focus, March 2018.
Global Regulatory & Submissions
Regulatory Submission Tracking and Management. Regulatory Affairs Journal, January 2003, pg. 15-18
Labelling
Proposed new pharmaceutical and biologic labeling. Focus; December 2001, pg. 25-31.
Safety/Complaint Handling
Choosing and implementing an electronic system for serious adverse event reporting. Applied Clinical Trials; October 2001, pg. 40-48.
Complaint Handling Systems: Are you using a square peg for a round system? Focus; February 2002, pg. 28-32
Combination Devices
Combination products in the US: Navigating the regulatory jungle. Focus, May 2002, pg. 17-25.
Templates
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.
Regulatory Intelligence Tools Compendium 2017. "Regulatory Focus. February 2017. Regulatory Affairs Professionals Society.