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Description
ClinChoice excels in overseeing international regulatory information by leveraging advanced technology, a comprehensive grasp of both global and local regulations, and exceptional data management techniques. By harnessing its regulatory affairs and technological expertise, ClinChoice aids organizations in effectively handling their regulatory data. Our team of consultants offers essential data maintenance assistance within regulatory information management system (RIMS) software, facilitating timely application submissions, approvals, and renewals while enhancing operational efficiency and monitoring. We support the management and oversight of the drug registration process, enabling pharmaceutical and medical device manufacturers to maintain visibility and track all regulatory details. With our guidance, organizations can formulate both immediate and long-term strategies that ensure compliance with submission deadlines, all while minimizing disruption to their everyday operations, ultimately contributing to a smoother regulatory journey. This strategic partnership empowers companies to navigate the complexities of compliance with greater confidence and agility.
Description
Kivo offers an innovative solution for sponsors and CROs, providing an economical document and process management platform that enables life sciences teams to efficiently accomplish their tasks within a single, user-friendly, and compliant environment. By integrating DMS, RIM, QMS, eTMF, and eCTD functionalities, Kivo allows teams in pharmaceuticals, biotechnology, medical devices, and biologics to handle regulated documents, quality management activities, clinical trial documentation, regulatory submissions, and workflow processes without the hassle of using multiple disconnected tools. With Kivo’s Document Management System, users can manage controlled documents and automate processes while ensuring project oversight, corporate documentation, and readiness for due diligence in a centralized manner, featuring version control, collaboration tools, audit trails, search capabilities, workflow automation, and Part 11-compliant electronic signatures. Additionally, the RIM system enhances project management and correspondence, facilitates submission building and publishing handoff, provides eCTD viewing options, and streamlines dossier management and interactions with health authorities. Overall, Kivo equips life sciences teams with the necessary tools to maintain compliance and efficiency in their operations.
API Access
Has API
API Access
Has API
Integrations
Docusign
Gmail
Microsoft Word
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$1,800 per month
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
ClinChoice
Country
United States
Website
clinchoice.com/solutions/regulatory-affairs/regulatory-information-management/
Vendor Details
Company Name
Kivo
Founded
2021
Country
United States
Website
kivo.io
Product Features
Product Features
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
