Freyr is a Strategic Regulatory partner providing end-to-end Regulatory solutions and services to Innovator pharma companies during their innovator drug development process.
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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 scientific document translation Automation for Lifesciences organizations to solve scientific document Translation challenges.
Freyr IMPACT is a Cloud-hosted Regulatory Intelligence software that offers regulatory Intelligence portal & tracking support that effectively monitors, collects & updates information by analyzing current HA regulations.
Freyr SUBMIT Pro is one of the best eCTD Submission software that suits all kinds of Regulatory eCTD publishing and submission requirements across the globe.
Freyr Label 360 is a Regulatory Labeling Management Software that helps Pharmaceutical Companies in Managing global and regional labeling, CCDS creation and updation, core to local label alignment.
Freyr SPL-SPM tool is an easy to use SPL-SPM Software that manages SPL-pharma listing lifecycle & validates the output as per USFDA regulations with seamless SPL Submissions.
Freyr Submit PRO’s in-built eCTD Viewer’s design enables the users to review the Regulatory submissions prepared in the eCTD format standard used by the Lifesciences industry and various Regulatory authorities.
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 Artwork 360 is an easy-to-use Artwork PLM Tool that manages Artwork Workflow Management, Artwork Version Tracking, Artwork Proofing & Review, Artwork Digital Asset Library, Artwork Reports and Collaboration Between Stakeholders ect..