Freyrsolutions

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

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 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 cosmetic regulatory services in Malaysia that span across cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation as per NPRA regulation

Freyr provides food regulatory services in Malaysia that span across food product registration, classification, formulation, ingredient assessment, technical dossier compilation and submission as per NPRA regulations

Freyr provides medical device regulatory services in Malaysia that span across medical device registration, medical device classification and market entry as per NPRA regulatory requirements

Freyr provides pharma/Medicinal product regulatory services in Malaysia as per NPRA regulations during Medicinal Product Registration, classification, Market authorization, Dossier Gap analysis and compliant with ACTD

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 provides cosmetic regulatory services in Brazil as per ANIVSA during cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation

Freyr provides food regulatory services in Brazil as per ANIVSA and CTCAF during food product registration, food classification, formulation, ingredient assessment, technical dossier compilation and submission

Freyr provides medical device regulatory services in Brazil during medical device registration, medical device classification and market entry as per ANVISA regulatory requirements

Freyr provides pharma/Medicinal product regulatory services in Brazil as per ANVISA during Medicinal Product Registration, classification, Market authorization and Dossier Gap analysis

Freyr provides regulatory services and solutions in Brazil to comply with ANVISA for pharmaceuticals, 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