Freyrsolutions

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 regulatory services and solutions in Thailand to comply with Thailand FDA for pharma, medical device, cosmetics, and food supplement manufacturer companies

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 SPL/SPM is cloud hosted and On-premise software that supports in electronic product registration; listing management, Labeling Management, PI submission in SPL/SPM Format with Automated notification updates.

Freyr provides end to end regulatory support for Food/dietary supplements manufacturers in product registration/notification and classification across the globe.

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.

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 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 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 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 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 medical device manufacturers outside the Switzerland as per Swissmedic regulations.