Freyrsolutions

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.

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

Freyr provides US agent representation services for medical device manufacturers and serves as a liaison between manufacturing company and FDA to be compliant.

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.

Freyr provides post-Brexit regulatory scenarios for life Sciences manufacturers in UK & EU to be inline with new regulatory changes.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Freyr provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe.

Freyr SUBMIT Pro is one of the best eCTD software tool which helps Life science companies in various regulatory submissions to global health Authorities.

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

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

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 Health Canada.