Freyr provides regulatory support for medical device manufacturers in 513 g submission, which includes medical device classification, preparation & review of 513g application and interaction with agency to comply with CDRH, FDA.
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Freyr provides regulatory support for medical device manufacturers in 510k submission (510 k premarket notification) to USFDA, which include predicate device identification, 510k application compilation, gap analysis, publishing, creation & validation of e-copy, device listing for compliant market entry.
Freyr provides Swiss Authorized Representative (CH-REP) services to foreign medical device manufacturers for their product registration and market entry in Switzerland and acts as a single point of contact in the Country for liaison with Regulatory Agency.
Freyr provides United Kingdom Responsible Person (UKRP) services to foreign medical device manufacturers in product registration and market entry in the UK and acts as a single point of contact in the Country for liaison with Regulatory Agency.
Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe.
Freyr SPL-SPM tool is an easy to use SPL-SPM Software that manages SPL-pharma listing lifecycle & validates the output as per USFDA regulations with seamless SPL Submissions.
Freyr Label 360 is a Regulatory Labeling Management Software that helps Pharmaceutical Companies in Managing global and regional labeling, CCDS creation and updation, core to local label alignment.
Freyr SUBMIT Pro is one of the best eCTD Submission software that suits all kinds of Regulatory eCTD publishing and submission requirements across the globe.
Freyr IMPACT is a Cloud-hosted Regulatory Intelligence software that offers regulatory Intelligence portal & tracking support that effectively monitors, collects & updates information by analyzing current HA regulations.
Freyr SPL/SPM is cloud hosted and On-premise software that supports in electronic pharma registration & listing management, Labeling Management, PI submission in SPL/SPM Format with Automated notification updates.
Freyr label 360 is a Pharmaceutical Labeling Software that Supports End to End Label Management, Label Tracking and Deviation Management for Pharmaceutical Companies across the Globe.
Freyr SUBMIT Pro is one of the best eCTD software tool which helps Life science companies in various regulatory submissions to global health Authorities.
Freyr provides Regulatory Software, Automation and Digital Transformation Solutions to support Global Lifesciences companies.