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

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 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 medical device manufacturers outside the UK as per MHRA regulations.

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 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 Reports provide Regulatory Intelligence, Market Intelligence, Trend Analysis Reports which include information on global/regional Regulatory guidelines, market trends, forecasts; insights, market analysis, competitive intelligence, opportunity, market potential as per region specific HA’s across the globe.

Freyr provides regulatory services and solutions in Mexico to comply with COFEPRIS for pharma, medical device, cosmetics and food supplement manufacturer companies.

Freyr provides regulatory and product registration support in Nigeria to comply with NAFDAC to pharma, medical device, cosmetics, and food supplement manufacturer companies.