Intelligence
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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
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
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
Labelling
Safety/Complaint Handling
Combination Devices
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.