Freyrsolutions

Freyr provides regulatory services and solutions in Thailand to comply with Thailand FDA for pharma, medical device, cosmetics, and food supplement manufacturer companies.

Freyr provides regulatory services and solutions in Sri Lanka to comply with NMRA to pharma, medical device, cosmetics and food supplement manufacturer companies.

Freyr provides regulatory services and solutions in India to comply with CDSCO regulations for pharmaceuticals, medical devices, cosmetics, and food supplements manufacturing companies.

Freyr 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 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 provides US FDA Medical device registration services for device manufacturers that span across preparation & compilation of necessary documents for 510(k) submissions and successful FDA medical device establishment registration.

Freyr provides FDA De-Novo Submission Services for medical device manufacturers that span across understanding De-Novo classification request and guiding throughout the classification process to obtain FDA clearance for novel devices.

Freyr provides US FDA 510(k) submission services for medical device manufacturers that span across preparation & compilation of necessary documents as per FDA 510(k) submission requirements/regulations.

Freyr assists medical device manufacturers in FDA 510(k) clearance process that includes different types of 510(k) application submissions and preparation of necessary documents to meet USFDA regulatory requirements.

Freyr provides USFDA 510(k) Consultant support for medical device manufacturers that span across 510(k) document preparation & customized solutions throughout 510(k) clearance process for compliant 510(k) submissions as per FDA regulations.

Freyr provides FDA Q-Submission consulting services for medical device manufacturers that span across pre-submission meeting, Post Q-Sub activities, and compilation of device documents as per USFDA regulations.

Freyr provides USFDA Medical device premarket approval process support for class III medical device manufacturers that span across preparation & review of the PMA application for successful PMA submissions as per US FDA regulations.

Freyr provides FDA 513(g) submission support for medical device manufacturers which includes US FDA medical device classification, preparation & review of 513(g) application to comply with CDRH, FDA regulations.

Freyr Provides Medical device regulatory consulting services for device manufacturers that include product registration and market entry in compliance with HA requirements across the globe.

Freyr Artwork 360 is one of the best Artwork Management Software tool which helps Life science companies to simplify the complexity of Artwork Management Process.

Freyr iREADY is a technology based Cosmetic Ingredient Database platform and it provides Regulatory compliance support to manufacturers for cosmetics ingredients and management of product formulae in global markets.

Freyr provides Swiss Authorized Representative(CH-REP) services for foreign medical device manufacturers and acts as Swiss distributor/importer of devices across Switzerland.

Freyr provides Swiss Authorized Representative(CH-REP) services for medical devices and IVD manufacturers in CE marking and labeling support as per Swissmedic regulations.

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.

Freyr provides United Kingdom Responsible Person(UKRP) services for foreign medical device manufacturers with end-to-end regulatory support for registration and market entry in UK.