Freyrsolutions

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 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 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 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 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 Swiss Authorized Representative(CH-REP) services for medical devices and IVD manufacturers in CE marking and labeling support as per Swissmedic regulations.

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 United Kingdom Responsible Person(UKRP) services for medical device manufacturers outside the UK as per MHRA regulations.

Freyr provides Swiss Authorized Representative(CH-REP) services for medical device manufacturers outside the Switzerland as per Swissmedic regulations.

Freyr provides scientific document translation Automation for Lifesciences organizations to solve scientific document Translation challenges.

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 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 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 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 Submit PRO’s in-built eCTD Viewer’s design enables the users to review the Regulatory submissions prepared in the eCTD format standard used by the Lifesciences industry and various Regulatory authorities.

Freyr provides regulatory services and solutions in Brazil to comply with ANVISA for pharmaceuticals, medical device, cosmetics and food supplement manufacturer companies

Freyr provides pharma/Medicinal product regulatory services in Brazil as per ANVISA during Medicinal Product Registration, classification, Market authorization and Dossier Gap analysis

Freyr provides medical device regulatory services in Brazil during medical device registration, medical device classification and market entry as per ANVISA regulatory requirements

Freyr provides food regulatory services in Brazil as per ANIVSA and CTCAF during food product registration, food classification, formulation, ingredient assessment, technical dossier compilation and submission

Freyr provides cosmetic regulatory services in Brazil as per ANIVSA during cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation