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 foreign medical device manufacturers with end-to-end regulatory support for registration and market entry in UK.
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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 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 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 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 helps in the Cosmetic product information file (PIF) compilation, review and maintenance support for ASEAN and Europe market as per the Health Authority Regulation
Freyr helps in Cosmetic go-to market and cosmetic responsible person services for EU, America and RoW regions for cosmetic product registration, classification, formulation & claims review, label review and product information file to comply with regional specific regulations.
Freyr provides Cosmetics Regulatory Intelligence/Information services for product classification, registration, claims, labeling & Packaging requirements, local agent requirements and regulation across globe
Freyr provides regional specific cosmetic regulatory services for launch of cosmetic products in the specific market as per the regional health authority regulations.
Freyr Cosmetics Regulatory Team helps in the cosmetic artwork design with label review, artwork creation and artwork solutions as per the health authority amendments and regulations
Freyr helps in Cosmetic testing services like microbiology test, challenge test, stability test, patch testing and efficacy testing for all aspects of cosmetic safety.
Freyr offers legal representative services to food supplement manufacturers in product registration, post-marketing and serve as a liaison between manufacturer and HA in taking up all applicable regional responsibilities.
Freyr helps food supplement manufacturers in product classification, formulation review, pre formulation assessment, reformulation and identifies prohibited ingredients to meet region specific compliance requirements.
Freyr provides regulatory intelligence services for the food supplements companies in product registration, classification, notification, licensing, Market Authorization Holder (MAH), legal representation requirements for compliant market entry across the globe.
Freyr assists food supplement manufacturers in product registration, notification, classification, GAP analysis, safety reporting, technical dossier compilation and submission for compliant market approvals.
Freyr provides end to end regulatory support for food supplement manufacturers in formulation review, ingredient assessment and region-specific food product classification.