Freyrsolutions

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.

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 Cosmetic Regulatory Services like formulation & ingredient review, label review, claims review, safety assessment & toxicology services, dossier compilation and market entry support.

Freyr Food Regulatory Affairs provides end to end regulatory support for Food/dietary supplements manufacturers in product notification, classification, and registration across the globe.

Freyr provides End to End Chemical Regulatory Compliance services to health care consumers like product registration, notification, Formulation review and We offer EU REACH and CLP Registration/Dossier Update, Hazard Communication for quick market access.

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 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 provides regulatory services and solutions in Thailand to comply with Thailand FDA 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 product registration; listing management, Labeling Management, PI submission in SPL/SPM Format with Automated notification updates.

Freyr provides end to end regulatory support for Food/dietary supplements manufacturers in product registration/notification and classification across the globe.