Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Essenvia enhances business value and improves operational efficiency across various teams and departments. It serves as a centralized hub for all regulatory data, facilitating collaborative document creation and reporting while helping to prevent technical holds, RTAs, and RFIs. This platform empowers the regulatory affairs team to speed up product launches, thus avoiding revenue losses associated with submission delays and missed renewals. It provides a comprehensive overview of the entire regulatory lifecycle, complete with executive dashboards, key performance indicators, and proactive alerts for global registrations, submissions, and change assessments. Essenvia acts as a Regulatory Information Management (RIM) Platform that streamlines regulatory workflows throughout the entire product lifecycle, enabling faster global market access and delivering significant business advantages. By consolidating all regulatory activities into one unified platform, businesses can accelerate their market entry. Additionally, it includes a central repository for all registration documents, which are linked to product master data, allowing users to effectively manage the product registration lifecycle on a country-by-country basis while ensuring compliance and efficiency.
Description
Samarind RMS offers an intelligent solution for overseeing your medical product information more effectively. With Samarind RMS, you can input data just once and utilize it repeatedly as needed. For instance, an ‘INN’ can be registered once and applied to all associated IMA submissions, renewals, variations, PSURs, and XEVMPD submissions. This principle is applicable to all essential data maintained within the system, which has demonstrated its ability to enhance workflow efficiency and boost data quality. Our practical approach to system design and implementation allows clients to handle their licenses with ease and confidence, knowing that our single-source-of-truth™ strategy for regulatory affairs experts provides a comprehensive end-to-end solution. Additionally, our platform includes an electronic document management system (EDMS) equipped with version control, the creation of templates, and the capability to connect to external document management systems such as Documentum™ or SharePoint™, ensuring a seamless integration of all your documentation needs. Ultimately, Samarind RMS empowers users not only to manage their information but also to improve collaboration across different departments.
API Access
Has API
No
API Access
Has API
Yes
Integrations
Arena PLM
Yes
EQMS
Yes
Microsoft SharePoint
No
OpenText Documentum
No
Oracle Fusion Cloud PLM
Yes
Qualio
Yes
Integrations
Arena PLM
No
EQMS
No
Microsoft SharePoint
Yes
OpenText Documentum
Yes
Oracle Fusion Cloud PLM
No
Qualio
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
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
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
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
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
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Essenvia
Country
United States
Website
essenvia.com
Vendor Details
Company Name
Instem
Founded
1969
Country
United States
Website
www.instem.com/solutions/samarind-rms/