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features
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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

Screenshots View All

No images available

Integrations

Microsoft SharePoint Yes 

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

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Product Features

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