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Freyr provides regulatory support for medical device manufacturers in classification of their products as per the new European Medical device...

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Freyr provides regulatory support for medical device manufacturers in 510k submission (510 k premarket notification) to USFDA, which include...

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Freyr provides regulatory support for medical device manufacturers in 513 g submission, which includes medical device classification, preparation...

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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...

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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...

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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...

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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...

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Freyr provides regulatory intelligence services for the food supplements companies in product registration, classification, notification,...

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Freyr helps food supplement manufacturers in product classification, formulation review, pre formulation assessment, reformulation and identifies...

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Freyr offers legal representative services to food supplement manufacturers in product registration, post-marketing and serve as a liaison between...

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Freyr assists food supplement manufacturers in technical dossier/document compilation, safety report preparation, review and gap analysis required...

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Freyr supports Nutraceuticals/Food/dietary supplements manufacturing companies in Food Claims Review services across the globe.
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Freyr provides food label review services for Nutraceuticals/dietary/food supplements companies to meet country-specific labeling compliance...

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Freyr offers Nutraceuticals/Food/dietary supplements health claims services, which includes claims substantiation, formulation review, food label...

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This article talks about the Japan's Consumer Affairs Agency (CAA) revised labeling standards for food products manufacturers for compliant market...

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This article talks about the Health Canada's Regulatory standards and authorization pathways for face shields market entry in Canada.
This...

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This article talks about the FDA's final guidance on multiple function device products' pre-market review policy and submission regulations for...

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This article talks about the MHRA (Medicines and Healthcare products Regulatory Agency) issued post transition guidance on Pharmacovigilance (PV...

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This article talks about the Mexico's COFEPRIS (The Federal Commission for Protection against Sanitary Risk) established a new electronic...

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Couple of months back we thoroughly discussed about FDA's expedited Regulatory pathways during medical emergencies. In that specific explanation...

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MHRA has published guidance on the new rules that will govern the regulation of medical devices and IVDs placed in Great Britain and EU market,...

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It is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December...

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As we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19...

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This article talks about the EMA's temporary updated guidance on GMP(Good Manufacturing Practices) and GDP(Good Distribution Practices) regulatory...

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Freyr's Generics Regulatory services support clients with Regulatory strategy, lifecycle management, submission planning, compilation and...

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Biological medicinal products are promising solutions in the prevention and treatment of several life-threatening, chronic diseases, and health...

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Freyr provides pharmaceuticals Regulatory affairs services enable Life Sciences, Consumer Pharma and Bio-Med companies to understand and...

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Freyr Provide the SPL/SPM Software support across entire value-chain with presence in multiple locations like US, Canada, UK, etc.
Freyr...

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Request a Demo for Freyr SPL/SMM software offered in cloud Hosted and on-premise deployment model, which suits all SPL & SPM submission...

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Request a quote for Freyr SPL/SMM Software, which adheres with 21 CFR Part 11 standards for seamless SPL/SPM submissions to comply with USFDA and...

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