Freyr provides regulatory support for medical device manufacturers in classification of their products as per the new European Medical device...
Freyr provides regulatory support for medical device manufacturers in 510k submission (510 k premarket notification) to USFDA, which include...
Freyr provides regulatory support for medical device manufacturers in 513 g submission, which includes medical device classification, preparation...
Freyr acts as an authorized representative(AR) on behalf of the foreign medical device and In-Vitro Diagnostics (IVD) manufacturers in...
Freyr acts as a local authorized representative (AR) on behalf of foreign medical device manufacturers in registration and market entry of their...
Freyr provides US agent representation services for medical device manufacturers and serves as a liaison between manufacturing company and FDA to...
Freyr acts as a European Authorised Representative (EAR/EC REP) for foreign medical device manufacturers in Europe to ensure their products are...
Freyr provides regulatory intelligence services for the food supplements companies in product registration, classification, notification,...
Freyr helps food supplement manufacturers in product classification, formulation review, pre formulation assessment, reformulation and identifies...
Freyr offers legal representative services to food supplement manufacturers in product registration, post-marketing and serve as a liaison between...
Freyr assists food supplement manufacturers in technical dossier/document compilation, safety report preparation, review and gap analysis required...
Freyr supports Nutraceuticals/Food/dietary supplements manufacturing companies in Food Claims Review services across the globe. Keywords:...
Freyr provides food label review services for Nutraceuticals/dietary/food supplements companies to meet country-specific labeling compliance...
Freyr offers Nutraceuticals/Food/dietary supplements health claims services, which includes claims substantiation, formulation review, food label...
This article talks about the Japan's Consumer Affairs Agency (CAA) revised labeling standards for food products manufacturers for compliant market...
This article talks about the Health Canada's Regulatory standards and authorization pathways for face shields market entry in Canada. This...
This article talks about the FDA's final guidance on multiple function device products' pre-market review policy and submission regulations for...
This article talks about the MHRA (Medicines and Healthcare products Regulatory Agency) issued post transition guidance on Pharmacovigilance (PV...
This article talks about the Mexico's COFEPRIS (The Federal Commission for Protection against Sanitary Risk) established a new electronic...
Couple of months back we thoroughly discussed about FDA's expedited Regulatory pathways during medical emergencies. In that specific explanation...
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,...
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...
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...
This article talks about the EMA's temporary updated guidance on GMP(Good Manufacturing Practices) and GDP(Good Distribution Practices) regulatory...
Freyr's Generics Regulatory services support clients with Regulatory strategy, lifecycle management, submission planning, compilation and...
Biological medicinal products are promising solutions in the prevention and treatment of several life-threatening, chronic diseases, and health...
Freyr provides pharmaceuticals Regulatory affairs services enable Life Sciences, Consumer Pharma and Bio-Med companies to understand and...
Freyr Provide the SPL/SPM Software support across entire value-chain with presence in multiple locations like US, Canada, UK, etc. Freyr...
Request a Demo for Freyr SPL/SMM software offered in cloud Hosted and on-premise deployment model, which suits all SPL & SPM submission...
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...