Freyr’s regulatory services in India for Diagnostic Kits span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.
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Freyr’s regulatory services in USA for Diagnostic Kits span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.
Contact Freyr for Nigeria End-to-End regulatory services to comply with NAFDAC regulatory Requirements for Drugs, Medical Devices, Cosmetics, Food Supplement Product registrations.
Freyr provides cosmetic regulatory services in Nigeria as per NAFDAC during cosmetic product registration, classification, Notification, formulation, clams review, CPSR and technical dossier compilation.
Freyr provides food supplements regulatory services in Nigeria as per NAFDAC during food product registration, classification, formulation, ingredient assessment and technical dossier compilation.
Freyr provides medical device regulatory services in Nigeria during medical device registration, classification, and licensing as per NAFDAC regulatory requirements.
Freyr provides pharma/Drug product regulatory support in Nigeria to comply with LFN, NAFDAC during Drug Product Registration, Market authorization, Dossier Gap analysis and Product Approval Meetings.
Freyr provides regulatory and product registration support in Nigeria to comply with NAFDAC to pharma, medical device, cosmetics, and food supplement manufacturer companies.
Contact Freyr for End-to-End regulatory services in Sri Lanka to comply with NMRA regulatory Requirements.
Freyr provides cosmetic regulatory services in Sri Lanka as per NMRA and CESC during cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation.
Freyr provides food regulatory services in Sri Lanka as per NMRA and FCA during food product registration, classification, formulation, ingredient assessment and technical dossier compilation.
Freyr provides medical device regulatory services in Sri Lanka during medical device registration, classification and licensing as per NMRA regulatory requirements.
Freyr provides pharma/Medicinal product regulatory services in Sri Lanka as per NMRA during Medicinal Product Registration, Market authorization and Dossier Gap analysis.
Freyr provides regulatory services and solutions in Sri Lanka to comply with NMRA to pharma, medical device, cosmetics and food supplement manufacturer companies.
Freyr helps medical device manufacturers with language translation, editing of medical device technical information in IFU, DSURs, SUSARs, Package inserts & labels for submission & approval process as per targeted regional languages with compliance to ISO 17100:2015 & ISO 9001:2008 standards.
Freyr provides Staff Augmentation Consulting services for medical device manufacturers that span across several Regulatory functionalities from associate to expert level resources and 24X7 time zone coverage model to support multiple time zone and office coverage.
Freyr provides regulatory supports for medical devices and In-vitro diagnostics (IVD) manufacturers in registration, regulatory submissions, dossier compilation, GAP analysis, premarket notification, local agent services and classification as per country-specific regulatory requirements for compliant market entry.
Freyr provides regulatory strategy consulting services for medical device manufacturers looking for global expansion in complex markets like APAC, MENA & LATAM and supports in device registration, classification, assistance with notified body selection and regulatory submissions.
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 regulatory intelligence services for medical device manufacturers to meet region-specific health authority requirements for compliant market entry of their products and provides comprehensive regulatory Intelligence reports corresponding to organizational needs basing on the region and device type.