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Freyr provides end-to-end regulatory services for medical devices manufacturers in Europe to comply with the new EU MDR regulations for successful market entry and also provides necessary Regulatory actions needed for the transition.
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Freyr provides regulatory support for medical device manufacturers in classification of their products as per the new European Medical device regulation (EU MDR)/In-vitro diagnostic regulation (IVDR) for product compliance.
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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
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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.
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Freyr acts as an authorized representative(AR) on behalf of the foreign medical device and In-Vitro Diagnostics (IVD) manufacturers in registration, pre-certification, post-approval, Marketing Authorization Holder (MAH) Services and also support for the Change of Legal Representative and Agency Interaction in Regional
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Freyr acts as a local authorized representative (AR) on behalf of foreign medical device manufacturers in registration and market entry of their products in ROW countries and acts as a single point of contact in the Country for liaison with Regulatory Agency.
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Freyr provides US agent representation services for medical device manufacturers and serves as a liaison between manufacturing company and FDA to be compliant.
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Freyr acts as a European Authorised Representative (EAR/EC REP) for foreign medical device manufacturers in Europe to ensure their products are compliant with the European Directives and acts as a single Point of Contact in the Country for Liaison with Regulatory Agency.
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Freyr provides UKRP services and Key takeaways for foreign medical device manufacturers to comply with MHRA regulations and market entry of the product in the UK.
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Freyr provides United Kingdom Responsible Person(UKRP) services for foreign medical device manufacturers with end-to-end regulatory support for registration and market entry of devices in UK.
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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.
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Freyr provides UKRP services for foreign medical device manufacturers in acting as their UK responsible person and takes key responsibilities to meet MHRA regulatory requirements.
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Freyr provides United Kingdom Responsible Person(UKRP) services for medical device manufacturers outside the UK in MHRA registration and UKCA mark for their products.
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Freyr provides UKRP support during Medical Device registration with MHRA on behalf of the foreign manufacturer.
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Freyr acts as a United Kingdom Responsible Person (UKRP) for medical device manufacturers on their behalf for product registration and UK market entry
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Freyr provides post-Brexit regulatory scenarios for life Sciences manufacturers in UK & EU to be inline with new regulatory changes.
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Freyr provides Brexit regulatory services for life science companies in most Affected areas like Artwork/Labelling/Packaging, Clinical Trials, GMP, MRP/DCP National/Central Procedure, Pharmacovigilance and Trade Barriers.
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Freyr provides Global End-to-End post-Brexit regulatory services for Life sciences companies which include Pharmaceuticals, Medical devices, Cosmetics and Food supplements for compliant product market entry.
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Freyr provides End-to-end post-Brexit regulatory services in European Union for Life sciences companies which include Pharmaceuticals, Medical devices, Cosmetics and Food supplements for compliant product market entry.
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Freyr provides End-to-end post-Brexit regulatory services in United Kingdom for Life sciences companies which include Pharmaceuticals, Medical devices, Cosmetics and Food supplements for compliant product market entry.
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