Writing a regulatory document is a difficult and time-consuming task. It is because of the presence of a large amount of data and strictly following the regulatory guidelines. Robotic process automation and artificial intelligence help in easing the load on regulatory medical writers. https://www.smiqgen.com/automation-in-regulatory-medical-writing-an-overview/

1. AUTOMATION (RPA AND AI) IN
REGULATORY MEDICAL WRITING

2. INTRODUCTION
Writing a regulatory document is
a difficult and time-consuming
task. It is because of the presence
of a large amount of data and
strictly following the regulatory
guidelines. Robotic process
automation and artificial
intelligence help in easing the
load on regulatory medical
writers.

3. REGULATORY MEDICAL
WRITING
Regulatory medical writers help the
pharmaceutical, biotechnology, and medical device
organization to apply for the approval of medical
drugs and devices. The regulatory writers are
experts in understanding the procedures, formats,
and guidelines of respective drug and medical
device regulatory authorities. Further, the
regulatory writer also helps filing several
documents, such as post-marketing surveillance or
pharmacovigilance obligations after the approval.

4. Contd…..
The regulatory medical
writers are employed by the
pharmaceutical companies
and several clinical research
organizations that help them
to develop complex
regulatory documents. The
regulatory documents may
include the protocols,
synopsis, rationale and
justification, and other

5. CHALLENGES IN REGULATORY MEDICAL
WRITING
Regulatory medical writing has
several challenges. Some of the
challenges are inherent to the
regulatory domain, while the
other challenges are commonly
present in almost all fields
of medical writing. Some of the
challenges of regulatory medical
writing are:

6. Contd…..
 More complex and time-consuming: As compared to other medical
writing domains, like medical communication and medical
branding, regulatory medical writing is more complex and required
required an in-depth understanding of the formulation under
consideration.
 Time-restriction: Although all medical documents have time
limitations, the consequences of lapsing the final date in filing the
the regulatory document are serious. Structured: The challenges in
challenges in writing the regulatory documents are that they are
are more structured, and it is necessary all the time to maintain
maintain consistency
 Accuracy and consistency: The content should be accurate,
consistent, and without any ambiguity. Failing this may result in

7. ROBOTIC PROCESS AUTOMATION IN
REGULATORY WRITING
There are complexities in the drug regulatory
environment. Increased document strictness, frequently
changing the guidelines, the addition of new
requirements, and the incorporation of additional data
requirements result in the demands for more advanced
technological solutions.
Robotic process automation is one such solution that
may help in managing the drug regulatory complexity. It
offers several advantages to the people working in drug
regulatory departments. There are several types of
robotic process automation.

8. Contd…..
Regulatory Process Automation
also helps in checking the
documents that are to be
submitted for regulatory
approval. The automated
process may help in checking
the setting and the bookmarks.
It also helps in arranging a lot of
data that is coming from the
clinical research organizations
in case of approval of a drug that

9. ARTIFICIAL INTELLIGENCE IN
REGULATORY WRITING
Artificial intelligence significantly changed the
regulatory writing domain. The number of regulatory
filings is increasing and simultaneous clinical trials of
several drugs are under process. It will result in the
generation of a lot of complex data. Artificial
intelligence developed specifically for regulatory
affairs helps in providing the updated regulatory
requirements from several regulatory authorities,
such as USFDA, UK-MHRA, TGA, and Health
Canada.

10. Contd…..
Artificial intelligence also helps
in managing the drug
development process and
ensuring that everything is
streamlined as per the
requirements of the regulatory
authority. Data mining and data
analysis are the other functions
performed by artificial
intelligence in regulatory affairs.

11. Contact Us
Email - info@smiqgen.com
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Website - https://www.smiqgen.com/