Freyr provides regulatory services to Generic medicine manufacturers in post-approval changes and submissions to European health authorities
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Freyr provides Regulatory strategic consulting and resources services like Market Authorisation Holder (MAH), local representative, Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) services
Freyr provides Brexit regulatory services to Generic medicine manufacturers for those who are ready to market their products in United Kingdom (UK) and Europe (EU)
Freyr provides regulatory services for the queries related to the sunset clause and understanding the guidance related to sunset clause.
Freyr provides regulatory services in Canada to Generic medicine manufacturers/ANDS holders in regulatory submission strategies for submission timelines, documents required for submission, approval process and registering generic medicine as per Health Canada requirements
Freyr provides regulatory support in managing and updating the Drug Master File (DMF) as per Health Canada guidelines and helps in Master file submissions in eCTD format.
Freyr provides regulatory support in ANDS change control evaluation/assessment, post-approval submission strategy and preparation of change-related submission packages as per Health Canada requirements
Freyr helps Generic pharma manufacturers/ANDS holders in Health Canada (HC) interactions which include discussing and clarification of potential risks and issues related to their ANDS applications for fast approvals of generics drug products.
Freyr provides regulatory service in Canada to Generic medicine manufacturers/ANDS holders for preparation, review, and submission of Abbreviated New Drug Submissions (ANDS) as per Health Canada requirements.
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 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.