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.
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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 provides scientific document translation Automation for Lifesciences organizations to solve scientific document Translation challenges.
Freyr provides regulatory support to the medical device manufacturers in De-Novo registration of medical devices in the USA that span across classification, Pre-Submission/Q-Submission meeting request, risk benefit determination, De-Novo submission package compilation, publishing and creation for Pre-Submissions.
Freyr provides Swiss Authorized Representative(CH-REP) services for foreign medical device manufacturers and acts as Swiss distributor/importer of devices across Switzerland.
Freyr provides Swiss Authorized Representative(CH-REP) services for medical devices and IVD manufacturers in CE marking and labeling support as per Swissmedic regulations.
Freyr provides United Kingdom Responsible Person(UKRP) services for medical devices and IVD manufacturers that span across registration, UKCA marking, UK CE marking, UKNI marking and labeling support as per MHRA regulations.
Freyr provides United Kingdom Responsible Person(UKRP) services for foreign medical device manufacturers with end-to-end regulatory support for registration and market entry in UK.
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.
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 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 regulatory services and solutions in Sri Lanka to comply with NMRA to pharma, medical device, cosmetics and food supplement manufacturer companies.
Freyr Artwork 360 is one of the best Artwork Management Software tool which helps Life science companies to simplify the complexity of Artwork Management Process
Freyr provides regulatory services and solutions in Thailand to comply with Thailand FDA for pharma, medical device, cosmetics, and food supplement manufacturer companies
Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU.Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU.
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 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 provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification 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 SUBMIT Pro is one of the best eCTD software tool which helps Life science companies in various regulatory submissions to global health Authorities.