Innovatum (eLabeling / eIFU + ePIC)
Cruxi Inc.
Cruxi offers an AI-powered platform simplifying medical device regulatory submissions to the FDA and global markets. They provide 14 services from device classification to final submission packages.
Cruxi provides an AI-powered platform designed to streamline medical device regulatory submissions. Their services cover the entire process, from initial device classification to final submission packages for FDA and global markets. They offer 14 distinct regulatory services, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), and IDE Submissions. The platform leverages intelligent automation, automated compliance checks, and expert guidance to simplify complex regulatory pathways. Cruxi aims to be a comprehensive solution for all regulatory needs, utilizing AI workflows to enhance efficiency and compliance for medical device manufacturers.
About
**Who they are**
Innovatum (eLabeling / eIFU + ePIC) provides enterprise labeling and regulatory data management solutions for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers. They offer their ROBAR Enterprise Label Management System, which can be deployed on-premises, hosted, or as SaaS.
**Expertise & scope**
* End-to-end life sciences labeling solutions
* Regulatory data management, including RIMS and PIMS data integration for label printing
* Management of bidirectional regulatory data submissions and approvals using technologies like HL7
* Solutions available for on-premises, hosted, or SaaS deployments, with hosted and SaaS options being single-tenant for enhanced security
* Support and project management delivered directly by Innovatum, with problem resolutions typically within minutes
**Reputation / proof points**
* ISO 9001:2015 Certified
Innovatum (eLabeling / eIFU + ePIC) provides enterprise labeling and regulatory data management solutions for FDA-regulated pharmaceutical, medical device, and biotechnology manufacturers. They offer their ROBAR Enterprise Label Management System, which can be deployed on-premises, hosted, or as SaaS.
**Expertise & scope**
* End-to-end life sciences labeling solutions
* Regulatory data management, including RIMS and PIMS data integration for label printing
* Management of bidirectional regulatory data submissions and approvals using technologies like HL7
* Solutions available for on-premises, hosted, or SaaS deployments, with hosted and SaaS options being single-tenant for enhanced security
* Support and project management delivered directly by Innovatum, with problem resolutions typically within minutes
**Reputation / proof points**
* ISO 9001:2015 Certified
Additional information
Innovatum emphasizes a high level of direct customer support, stating that phones are answered by people, all support is tier one level provided by project managers, and problem resolutions are achieved quickly. Information on the effective use of their ROBAR system is delivered directly to customers under maintenance, avoiding reliance on external support blogs or user groups. Their ROBAR systems can be configured for on-premises, hosted, or SaaS environments, with hosted and SaaS solutions utilizing single-tenancy for dedicated servers, aiming to provide strong security and minimize business interruptions.
Key Highlights
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Offers ROBAR Enterprise Label Management System 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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Provides end-to-end life sciences labeling solutions.
Source
“End to End Life Sciences Labeling Solutions”
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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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Supports bidirectional regulatory data submissions and approvals.
Source
“Managing the bidirectional process of regulatory data submissions and approvals using requisite technologies such as HL7 and others.”
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ROBAR systems are available as on premises, hosted, or SaaS, with single-tenant options.
Source
“ROBAR systems from Innovatum are available as on premises, hosted, or SaaS. Hosted and SaaS ROBAR solutions are always single-tenant.”
Certifications & Trust Signals
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ISO 9001:2015 Certified
Source
“ISO 9001:2015 Certification”
Buyer Snapshot
Best for
- Manufacturers in the pharmaceutical, medical device, and biotechnology sectors requiring robust labeling and data management.
How engagement typically works
- Direct support from project managers
- On-demand information delivery under maintenance agreements
Typical deliverables
- ROBAR Enterprise Label Management System
- Regulatory data management services
- Label printing data integration
- Submission process management
Good to know
- Best when a dedicated, direct support model is preferred over community-based solutions.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
eIFU & Implant Card Platform
Pricing model:
Custom pricing
Hosting Model:
SaaS
Paper On Request Fulfillment:
Not supported
Implant Card Support:
Not supported
Additional eifu_platform Details
Hosting Details
ROBAR systems are available as on premises, hosted, or SaaS. Hosted and SaaS ROBAR solutions are single-tenant.
Compliance Certifications
ISO 9001:2015
