Freyrsolutions

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

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

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 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 Swiss Authorized Representative (CH-REP) services to foreign medical device manufacturers for their product registration and market entry in Switzerland and acts as a single point of contact in the Country for liaison with Regulatory Agency.

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.