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Average Ratings 0 Ratings
Description
The K2C PSMF Solution represents an innovative methodology for overseeing the Pharmacovigilance System Master File. Periodic updates to this document are essential whenever there are noteworthy modifications in the pharmacovigilance procedures. Such modifications necessitate collaboration among various roles within the company to edit a document comprised of consistent paragraphs and annexes dictated by regulatory standards. However, coordinating edits can be challenging, especially since certain content must remain exclusive to specific editors and inaccessible to other contributors. The K2C solution addresses this complexity by treating individual paragraphs and annexes as separate documents, facilitating the creation of the final PSMF document through the merging of these various source materials. Additionally, the K2C PSMF Solution encompasses the management of contributions to the PSMF (including both paragraphs and annexes) as distinct entities, the regulation of access rights for both viewing and editing contributions, and comprehensive oversight of the entire document lifecycle, ensuring efficiency and compliance throughout the process. This streamlined approach enhances collaboration while maintaining regulatory adherence.
Description
RegAffairs AI serves as an advanced research assistant specifically designed for teams involved in regulatory affairs, compliance, and product stewardship. By posing a regulatory query in straightforward language, users can tap into a wealth of information drawn from 1,046 official regulation databases maintained by over 340 regulators across 43 different jurisdictions, which encompass areas such as chemicals, pharmaceuticals, food, cosmetics, pesticides, biocides, fashion, and environmental health and safety (EHS). Within just a few minutes, users receive a comprehensive answer, with each assertion meticulously linked to the precise regulation, annex entry, or judgment paragraph, allowing direct access to the original source document. The research trail is transparently displayed on the results page, detailing every search and document consulted by the agent, facilitating thorough verification and enabling legal teams to take over the findings. The information provided is strictly derived from the indexed official texts, ensuring that if there is no existing record on a matter, the response will clearly indicate that lack of information. Common inquiries include whether a substance remains on the list or is restricted, identifying changes following the most recent amendment, comparing differences between two markets, and determining who is obligated to notify by a certain deadline. Importantly, user questions are never utilized for training purposes, maintaining confidentiality and integrity. In essence, RegAffairs AI is a vital tool for ensuring compliance and navigating the complexities of regulatory landscapes.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Microsoft SharePoint
No
Pricing Details
€8,500 one-time payment
Free Trial
Yes
Free Version
No
Pricing Details
$100/month
Free Trial
No
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
K2C
Country
United Kingdom
Website
www.k2c.com/products/K2Pharma/PSMF.html
Vendor Details
Company Name
RegAffairs AI
Country
Portugal
Website
regaffairsai.com