Freyrsolutions

Freyr SPL-SPM Software is an cost-effective solution for your SPL-SPM submissions which has Automated Process for new SPL-SPM submissions and revisions, adheres with 21 CFR Part 11 HL7 standards.

Freyr Label 360 is a Drug labeling software for pharmaceutical Industry and it is a one stop solution for all regulatory labeling needs.

Freyr provides End-to-End Regulatory Services in Malaysia to the pharmaceuticals, Medical Device, Food Supplements, and Cosmetic Companies to comply with NPRA Regulations

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

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

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

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 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 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 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.