Innovatum — ROBAR (HL7 SPL + upload to GUDID)
Cruxi Inc.
Cruxi offers an AI-powered platform for streamlining medical device regulatory submissions, including FDA 510(k), De Novo, and PMA. They provide expert guidance and automated compliance checks.
Cruxi provides an AI-powered regulatory platform designed to simplify medical device submissions for FDA and global markets. Their services cover a range of regulatory needs, from FDA 510(k) and De Novo Classification Requests (eSTAR) to Q-Submissions, 513(g) Requests, PMA Supplements, and Humanitarian Device Exemptions (HDE). The platform features AI-driven workflows, automated compliance checks, and expert guidance to ensure efficiency and accuracy throughout the submission process. Cruxi aims to be a comprehensive solution for all regulatory requirements, offering 14 distinct services. They emphasize intelligent automation and expert support to navigate complex regulatory landscapes.
About
**Who they are**
Innovatum — ROBAR (HL7 SPL + upload to GUDID) is a regulated labeling software and consulting services company with over two decades of experience focused on life sciences labeling.
**Expertise & scope**
* Provides an Enterprise Label Management System (ROBAR) for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.
* Manages regulatory data as a Regulatory Information Management System (RIMS) and integrates with Product Information Management Systems (PIMS) for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Offers solutions for FDA UDI compliance and GUDID submissions.
* Supports both hosted and on-premises labeling solutions.
**Reputation / proof points**
* ISO 9001:2015 Certified.
Innovatum — ROBAR (HL7 SPL + upload to GUDID) is a regulated labeling software and consulting services company with over two decades of experience focused on life sciences labeling.
**Expertise & scope**
* Provides an Enterprise Label Management System (ROBAR) for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.
* Manages regulatory data as a Regulatory Information Management System (RIMS) and integrates with Product Information Management Systems (PIMS) for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Offers solutions for FDA UDI compliance and GUDID submissions.
* Supports both hosted and on-premises labeling solutions.
**Reputation / proof points**
* ISO 9001:2015 Certified.
Additional information
Innovatum's ROBAR system is available as on-premises, hosted, or SaaS solutions, with hosted and SaaS options always being single-tenant to ensure enhanced security and minimal business interruptions. The company emphasizes direct customer support, with phones answered by project managers who implement the product, aiming for problem resolution in minutes. Information on the effective use of the ROBAR system is delivered directly to customers under maintenance, avoiding reliance on external support blogs or user groups.
Key Highlights
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Offers an Enterprise Label Management System (ROBAR) for FDA-regulated industries.
Source
“Innovatum’s ROBAR Enterprise Label Management System for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.”
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Manages regulatory data as a RIMS and integrates with PIMS for label printing.
Source
“ROBAR MDM can be used to effectively manage regulatory data as a RIMS and provide it to ROBAR Labeling along with PIMS data for use in label printing.”
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Facilitates bidirectional regulatory data submissions and approvals using HL7.
Source
“Managing the bidirectional process of regulatory data submissions and approvals using requisite technologies such as HL7 and others.”
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Provides GUDID submission options and supports HL7 SPL.
Source
“GUDID submission options, however, is an area in which a few options present themselves.”
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ISO 9001:2015 Certified.
Source
“ISO 9001:2015 Certification”
Certifications & Trust Signals
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ISO 9001:2015 Certified.
Source
“ISO 9001:2015 Certification”
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Over 2 decades of experience in life sciences labeling.
Source
“Innovatum is a regulated labeling software and consulting services company; a prolific innovator in its industry, tightly focused on life sciences labeling for more than 2 decades.”
Buyer Snapshot
Best for
- FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers
- Companies needing robust regulatory data management and labeling solutions
How engagement typically works
- Direct support from project managers
- Direct delivery of system usage information
Typical deliverables
- ROBAR Enterprise Label Management System
- Regulatory data management
- HL7 SPL generation
- GUDID submission support
Good to know
- Best when requiring dedicated, high-touch support for life sciences labeling and data management.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA GUDID Submission Tools
Submission Route:
direct_spl
Generates Spl:
Yes
Handles Esgsubmission:
No
Validation Tools:
Yes
Gdsn Integration:
No
Additional gudid_submission_tools Details
Submission Route
direct_spl
Generates Spl
Yes
Handles Esgsubmission
No
Validation Tools
No
Gdsn Integration
No
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