The Regulatory Affairs Automation tools used in the Pharmaceutical Industry: An overview
Abstract
Automation is becoming increasingly prevalent in various industries, including healthcare and pharmaceuticals. The pharmaceutical business is influenced by a variety of worldwide trends, with one of the most significant being the use of automation technologies, which will have a transformative effect on the research and development of new pharmaceutical products as well as the speed and efficiency with which products reach patients in need. Regulatory automation is enabled by a variety of technology tools, such as Electronic Document Management Systems, Regulatory Information Management (RIM) Systems, Artificial Intelligence (AI) Analytics Tools, Natural Language Processing (NLP) Tools, and Submission Publishing Tools. Automation tools can be used to automate regulatory activities such as administrative work, dossier completion, data extraction, auditing, regulatory implementation as well as quality management. Automation tools establish process links and minimize complexity, resulting in a more efficient management system. Human-AI interaction creates new prospects in regulatory concerns. This article investigates the potential use of automation techniques in pharmaceutical regulatory concerns.
Downloads
References
https://www.freyrsolutions.com/blog/revolutionize-regulatory-publishing-submission-with-automation
2. Paul D, Sanap G, Shenoy S, Kalyane D, Kalia K, Tekade RK. Artificial intelligence in drug discovery and development. Drug Discov Today. 2021;26:80-93.
3. Challenges in eCTD Publishing & Submission Management. DDReg Pharma [Internet]. Ddregpharma; 2022 [cited 2024 Feb 01]. Available from:
https://resource.ddregpharma.com/blogs/challenges-in-ectd-publishing-submission-management/
4. Veeva Vault. Veeva Systems [Internet]. Veeva System; 2024 [cited 2024 Feb 11]. Available from:
https://www.veeva.com/products/enterprise-content-management/
5. Standardizing Content Management Across the Life Sciences Industry [Internet]. Veeva System; 2021 [cited 2024 Feb 11]. Available from:
https://www.veeva.com/wp-content/uploads/2021/04/Veeva-Reference-Model-Whitepaper.pdf
6. Best Regulatory Information Management (RIM) Systems. G2 [Internet]. G2; 2023 [cited 2024 Feb 12]. Available from:
https://www.g2.com/categories/regulatory-information-management-rim-systems
7. ArisGlobal Acquires Regulatory Data Application. Pharmaceutical commerce. [Internet]. Pharmaceutical commerce; 2023 [cited 2024 Feb 11]. Available from:
https://www.pharmaceuticalcommerce.com/view/arisglobal-acquires-regulatory-data-application
8. The Trending Role of Artificial Intelligence in the Pharmaceutical Industry [Internet]. Sartorius; 2020 [cited 2024 Feb 12]. Available from:
https://www.sartorius.com/en/knowledge/science-snippets/the-trending-role-of-artificial-intelligence-in-the-pharmaceutical-industry-599278
9. Varma R K. Axon Data Governance & Features Integration. Informatica [Internet]. informatica; 2024 [cited 2024 Feb 12]. Available from:
https://www.informatica.com/content/dam/informatica-cxp/techtuesdays-slides-pdf/Axon%20Data%20Governance%20and%20Feature%20Integration.pdf
10. NLP in Pharma – Authenticx. Authenticx. [Internet]. Authenticx; 2023 [cited 2024 Feb 12]. Available from: https://authenticx.com/page/nlp-in-pharma/#:~:text=NLP%20combines%20linguistics%20and%20computer,target%20patients%20for%20existing%20medications.
11. Linguamatics NLP. Linguamatics [Internet]. Linguamatics; 2023 [cited 2024 Feb 12]. Available from:
https://www.linguamatics.com/products/nlp-natural-language-processing
12. Dossier Submission Publishing Software. Ennov software for life [Internet]. Ennov; 2022 [cited 2024 Feb 11]. Available from:
https://en.ennov.com/solutions/regulatory/dossier/
13. Submission Management with LORENZ docuBridge LORENZ Life Sciences Group | Regulatory RIM System [Internet]. Lorenz; 2023 [cited 2024 Mar 02]. Available from:
https://www.lorenz.cc/Solutions/docuBridge/
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
