Freyrsolutions

Freyr provides Regulatory Software, Automation and Digital Transformation Solutions to support Global Lifesciences companies.

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

Freyr label 360 is a Pharmaceutical Labeling Software that Supports End to End Label Management, Label Tracking and Deviation Management for Pharmaceutical Companies across the Globe.

Freyr SPL/SPM is cloud hosted and On-premise software that supports in electronic Pharma registration & listing management, Labeling Management, PI submission in SPL/SPM Format with Automated notification updates.

Freyr provides Global Regulatory Artwork Management Services & Solutions for life sciences Industry, which include Artwork proofreading, Artwork packaging, Artwork Lifecycle management, Artwork Studio Services.

Freyr acts as a Swiss Authorized Representative(CH-REP) on behalf of foreign medical device manufacturers during registration and compliant market entry of their products as per Swissmedic 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 provides end to end regulatory support for medical device & IVD manufacturers in product registration, notification, classification across the globe.

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 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 Regulatory Services in Malaysia to the pharmaceuticals, Medical Device, Food Supplements, and Cosmetic Companies to comply with NPRA Regulations.

Freyr is a Strategic Regulatory partner providing end-to-end Regulatory solutions and services to Innovator pharma companies during their innovator drug development process.

Freyr provides end-to-end Regulatory Affairs services to the Biologics/Biosimilar product companies during BLA submission process, starting from pre-BLA/BPD meetings to further Life Cycle Management (LCM) of the various biological products.

Freyr provides Regulatory Affairs services during planning, preparation and submission of Clinical Trail Application to comply with Health Authority Requirements.

Freyr provides Regulatory Affairs services in handling submission of CTA applications/Investigational Medicinal Product Dossier (IMPD) as per EU requirements for different types of medicinal products like New drugs, Recombinant Protein Products, Vaccines, Stem Cell-Based Products etc.

Freyr provides Regulatory Affairs service support to the Innovator medicine companies during IND filing process, starting from pre-IND meetings to IND submission and further to regulatory compliance & maintenance.

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.