Freyrsolutions

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 cosmetic regulatory services in Malaysia that span across cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation as per NPRA regulation

Freyr provides food regulatory services in Malaysia that span across food product registration, classification, formulation, ingredient assessment, technical dossier compilation and submission as per NPRA regulations

Freyr provides medical device regulatory services in Malaysia that span across medical device registration, medical device classification and market entry as per NPRA regulatory requirements

Freyr provides pharma/Medicinal product regulatory services in Malaysia as per NPRA regulations during Medicinal Product Registration, classification, Market authorization, Dossier Gap analysis and compliant with ACTD

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 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 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.

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

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 Mexico to comply with COFEPRIS for pharma, medical device, cosmetics and food supplement manufacturer companies.

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.