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 it with Product Information Management System (PIMS) data for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Offers hosted or on-premises labeling solutions.
* Focuses on end-to-end life sciences labeling solutions.
**Reputation / proof points**
* ISO 9001:2015 Certified
* Known for consistent, extraordinary support, with project managers providing tier-one support.
* Offers direct delivery of system enhancements as part of maintenance, included in upgrades.
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 it with Product Information Management System (PIMS) data for label printing.
* Facilitates the bidirectional process of regulatory data submissions and approvals using technologies like HL7.
* Offers hosted or on-premises labeling solutions.
* Focuses on end-to-end life sciences labeling solutions.
**Reputation / proof points**
* ISO 9001:2015 Certified
* Known for consistent, extraordinary support, with project managers providing tier-one support.
* Offers direct delivery of system enhancements as part of maintenance, included in upgrades.
Additional information
Innovatum's ROBAR system is available in on-premises, hosted, or SaaS configurations, with hosted and SaaS solutions being single-tenant to ensure enhanced security and minimize business interruptions. They emphasize direct customer support, with phones answered by project managers who implement the product, aiming for rapid problem resolution. 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 manufacturers.
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 data 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 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.”
-
ISO 9001:2015 Certified.
Source
“ISO 9001:2015 Certification”
Certifications & Trust Signals
Buyer Snapshot
Best for
- FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers.
- Companies requiring robust regulatory data management and labeling solutions.
How engagement typically works
- Direct support from project managers.
- Direct delivery of system enhancements and information.
Typical deliverables
- Enterprise Label Management System (ROBAR).
- Regulatory data management (RIMS).
- HL7 SPL generation and submission support.
- Hosted or on-premises labeling solutions.
Good to know
- Best when a dedicated, end-to-end labeling and data management solution is required.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
FDA GUDID Submission Tools
Submission Route:
direct_spl
Generates Spl:
Yes
Handles Esgsubmission:
Yes
Validation Tools:
Yes
Additional gudid_submission_tools Details
Submission Route
direct_spl
Generates Spl
Yes
Handles Esgsubmission
No
Validation Tools
No
Gdsn Integration
No
