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 life sciences labeling software and consulting services company with over two decades of industry focus. They specialize in providing end-to-end solutions for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.
**Expertise & scope**
* Manages regulatory data as a Regulatory Information Management System (RIMS) and integrates it with Product Information Management Systems (PIMS) for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Offers hosted or on-premises labeling solutions.
* Provides regulatory data management and submission services.
* Supports GUDID submissions, noting the GUDID Web Interface is practical for companies with fewer than 100 SKUs, suggesting a need for more robust approaches for larger catalogs.
**Reputation / proof points**
* ISO 9001:2015 Certified
* Known for consistent, extraordinary support, with support provided by project managers who implement the product.
Innovatum — ROBAR (HL7 SPL + upload to GUDID) is a life sciences labeling software and consulting services company with over two decades of industry focus. They specialize in providing end-to-end solutions for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.
**Expertise & scope**
* Manages regulatory data as a Regulatory Information Management System (RIMS) and integrates it with Product Information Management Systems (PIMS) for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Offers hosted or on-premises labeling solutions.
* Provides regulatory data management and submission services.
* Supports GUDID submissions, noting the GUDID Web Interface is practical for companies with fewer than 100 SKUs, suggesting a need for more robust approaches for larger catalogs.
**Reputation / proof points**
* ISO 9001:2015 Certified
* Known for consistent, extraordinary support, with support provided by project managers who implement the product.
Additional information
Innovatum's ROBAR Enterprise Label Management System is designed for FDA-regulated entities. They emphasize their dedicated support model, where phones are answered by project managers, aiming for rapid problem resolution. Their systems are available in on-premises, hosted, or SaaS configurations, with hosted and SaaS solutions being single-tenant to ensure security and minimize business interruptions. 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
-
ISO 9001:2015 Certified
Source
“ISO 9001:2015 Certification”
-
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 technologies such as HL7.
Source
“Managing the bidirectional process of regulatory data submissions and approvals using requisite technologies such as HL7 and others.”
-
Offers dedicated, tier-one support provided by project managers.
Source
“all support is tier one level provided by project managers who implement the product”
Certifications & Trust Signals
-
Over two decades of focus on life sciences labeling.
Source
“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 to manage regulatory data for labeling and submissions
- Organizations seeking robust solutions beyond basic GUDID web interface entry
How engagement typically works
- Direct support from project managers
- On-premises, hosted, or SaaS deployment options
- Direct delivery of system usage information
Typical deliverables
- ROBAR Enterprise Label Management System
- Regulatory Data Management
- HL7 SPL generation and submission support
- GUDID submission capabilities
- Label printing data integration
Good to know
- Best when requiring integrated regulatory data management and labeling solutions.
- Consideration for companies with over 100 SKUs needing a more robust submission approach than the GUDID Web Interface.
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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