freyr solutions
Freyr Provides global Regulatory Affairs services to the life science companies for their product development, registration, commercialization and launch of their products across the globe as per regional health Authority regulatory requirements
Freyr Provides global Regulatory Affairs services to the life science companies for their product development, registration, commercialization and launch of their products across the globe as per regional health Authority regulatory requirements.
Freyr provides Regulatory Affairs services to the generic medicinal product companies during ANDA submissions and filing process to explore the shortest route and timeframe to put your products in the market safely, aiming at ultimate commercial success.
Freyr provides Regulatory Affairs services to the Biologicals/Biosimilars product companies for BLA submission process, starting from pre-BLA meetings, Pre-Market approvals to submission of amendments/supplements, and further Life Cycle Management (LCM) of the various biological products
Freyr provides Regulatory Affairs services during DMF submission and filing with capabilities in managing of DMF (Types II, III & IV) for Drug substances, excipients, and packaging materials to comply with US FDA.
Freyr provides Regulatory Affairs services to the innovator medicinal companies for NDA (New Drug Application) filing process, starting from pre-NDA meetings to NDA annual reports submission and further life cycle management of the medicinal Product.
Freyr provides Regulatory Affairs service support to the innovator medicinal companies for Investigational New Drug Application (IND) filing process, starting from pre-IND meetings to IND submission and further regulatory compliance & maintenance.
Freyr provides Regulatory Affairs services to the generic medicinal product companies in Canada to handle generic application submissions (ANDS) to comply with Health Canada for product registration and approval procedures.
Freyr provides Regulatory Affairs services to innovator medicinal product companies in Health Canada New drug submission (NDS) process, starting from pre-NDS meetings to submission of Market Notification and further Life Cycle Management (LCM) activities.
Freyr provides Regulatory Affairs services during planning, preparation and submission of Clinical Trail Applications (CTA) in different countries for different types of medicinal products like small molecules, Recombinant Protein Products, Vaccines, cellular and gene therapy products etc.
Freyr provides Regulatory Affairs services to Drugs, Biologics, Cosmetics and Medical Device companies for entire product lifecycle management as per regional health authorities regulatory requirements
Freyr is a Global Regulatory Solutions and Services company Regulatory Strategy Submissions to post approval for Pharmaceutical companies across the globe.
