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Description

Introducing a comprehensive global regulatory affairs platform, featuring registration management tools and expert support from regulatory professionals worldwide. This system is essential for initiating, renewing, modifying, or transferring market access approvals for your medical devices or IVDs. With LICENSALE®'s user-friendly interface and real-time data capabilities, you gain access to complete project management tools, infographic analytics, a seamless collaboration space, future market access strategies, and detailed reporting features. This empowers you to oversee your global medtech registration processes effectively. Regulatory specialists from Arazy Group meticulously examine your compliance documents, providing guidance in the preparation and submission of your applications, and they liaise with authorities until you secure the necessary marketing approvals. Furthermore, LICENSALE® encompasses specific submission and compliance requirements tailored to your product across over 140 countries, with dedicated regulatory experts available to assist in navigating each market's unique challenges. By leveraging this system, you can streamline your regulatory processes and enhance your overall market entry strategy.

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

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Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$100/month
Free Trial No 
Free Version Yes 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
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) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
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

Arazy Group

Country

Canada

Website

arazygroup.com/licensale-2/

Vendor Details

Company Name

RegAffairs AI

Country

Portugal

Website

regaffairsai.com

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