Author: Chandrakala

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... Read More

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... Read More

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... Read More

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. For... Read More

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... Read More

Freyr provides Regulatory Affairs services during planning, preparation and submission of Clinical Trail Application to comply with Health Authority Requirements. To obtain a clinical trial authorization, a Clinical Trial Application... Read More

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.... Read More

Freyr is a Strategic Regulatory partner providing end-to-end Regulatory solutions and services to Innovator pharma companies during their innovator drug development process. A Strong Regulatory System Plays A Predominant Role in... Read More