Freyrsolutions

Freyr provides Regulatory Affairs services to the Innovator medicine companies during NDA filing process, starting from pre-NDA meetings to NDA submission and further life cycle management of the medicinal Product.

Freyr provides Regulatory Affairs services to Innovator medicine product companies during NDS process with Health Canada, starting from pre-NDS meetings to submission of NDS/Market Notification and further Life Cycle Management (LCM) activities.

Freyr provides clinical labeling services to Innovative pharmaceutical companies during creation & review of Investigational brochure (IB), Target Labeling (TL), DCDS, FDA Target Product Profile (TPP), EU-draft SmPC during Drug Development Process.

Freyr provides clinical trial auditing and monitoring services for both the clinical and bio-analytical phases of the Bioequivalence (BE) studies, Bioavailability (BA) studies, Clinical SOP preparation and review as per health authority regulations.

Freyr supports in delivering high-quality, comprehensive safety evaluation for ingredient and toxicological risk assessment (TRA) reports for pharmaceutical, cosmetics, medical devices, food and consumer products across the globe.

Freyr provides region specific Regulatory affairs and consulting services to the life science companies to launch their products in the new markets across the globe.

Freyr provides regulatory affairs consulting and partnering services to the life science companies during drug discovery, non-clinical & Clinical studies and Regulatory filings across globe

Freyr provides End-to-End Regulatory Services in Malaysia to the pharmaceuticals, Medical Device, Food Supplements, and Cosmetic Companies to comply with NPRA Regulations

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

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

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

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

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 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.

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 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.

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.