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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 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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Gonzalez questioned whether his remedy by authorities was as a result of he is Mexican.
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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 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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Freyr SUBMIT Pro is an cloud hosted, on-premise cost effective eCTD submission software with features like eCTD Submission tracker, Viewer, Validation and rDMS Integration.
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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.
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Freyr SUBMIT Pro is an prominent eCTD publishing Software with various features like Inbuilt eCTD validator and viewer, submission tracking, HA query management, rDMS integration and many more.
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Freyr provides United Kingdom Responsible Person (UKRP) services to foreign medical device manufacturers in product registration and market entry in the UK and acts as a single point of contact in the Country for liaison with Regulatory Agency.
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Freyr Australia provides End-to-End Regulatory Solutions & Services in Australia to the Pharma Innovator, Generics, Biologics, Medical Device, Food Supplements and Cosmetic Companies to comply with TGA Regulations.
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Freyr provides End-to-End Post Brexit regulatory support for Pharma, Medical Devices, Cosmetics and Food Supplements manufacturers who are willing to market their products in United Kingdom (UK) and EU.
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