Freyr - A Leader in Global Regulatory Solutions & Services

The Medical and Pharmaceuticals fields are one of the most complex industries. As it is directly involved with people's lives, the sector's seriousness can't be taken for granted. Freyr is one of the world's leading companies that supports life sciences companies through their entire Regulatory value-chain. It covers a series of services, including Regulatory Strategy, Intelligence, Dossiers, Submissions, etc., to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management, consulting, software, and other related functions. 

Freyr is a trusted Company that provides end-to-end Regulatory services across 8 of the Forbes Global Top 10 Healthcare/ Life Sciences, Mid-market $1+ Billion BioPharma, and Several Small-Medium, Fast Growing Life Sciences companies, CROs, and Standards agencies. It is one of the few global companies to have pioneered specialized Centers of Excellence (CoEs) exclusively focusing on the entire Regulatory value-chain, which are supported by rapidly growing global teams of 800+ Regulatory Professionals.

Regulatory Services for Generics

As the Generics industry has evolved and matured, it is being encountered with intense scrutiny from the global Regulatory Agencies. Thus, the need for specialized Generics Regulatory services has attained prime importance. It helps to improve capabilities by bringing new, safe, and cheaper Generics to markets.

Generic and Innovator drugs bear many similarities, except the pricing. It is also consumed in a manner similar to an Innovator drug; however, it is far more economical. With an objective to produce high-quality pharmaceutical formulations, Generics drug manufacturers strive to identify the most critical needs of patients across the globe by devoting their resources to developing safe, effective, and affordable healthcare solutions as an option to Innovator drugs.

Innovators are protected by patents and exclusivities that influence how and when a generic drug can be approved and marketed. Freyr's proven Generics Regulatory services include Compilation, review, and submission of about 40 ANDAs to multiple clients and have not received RTR for even one ANDA; end-to-end Regulatory support provided for generic manufacturers from the development stage of the product to post-approval submissions and lifecycle management.

Innovator Drugs Regulatory Services

Emerging innovations in science and technology have opened new avenues for the development of several novel drugs and advanced therapies intended for the treatment of various life-threatening diseases and health conditions. In recent decades, there has been a significant increase in incremental innovation and investments in the Biopharma sector towards research and the development of new drugs. Hence, it is expected that there will be a significant increase in the number of Investigational New Drugs (INDs), Investigational Medicinal Product Dossier (IMPDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biological License Applications (BLAs), under various therapeutic categories in future years. Applications are expected under various categories, including anti-cancer drugs, precision therapies, tissue & stem cell-based therapies, gene therapies, and so on.

Freyr has expertise in Regulatory strategies and route maps for the development & registration of innovator products. It also provides expert advice on mitigation plans for product developmental issues and submission risks. It monitors developmental programs on a periodic basis and assisting clients with Regulatory support, wherever needed.

CRO Regulatory Services

Clinical Research is one of the most critical areas in the Pharmaceutical Industry, which contributes greatly to the effective development of drugs by confirming their efficacy, safety, and bio-equivalency. Clinical Research has a vast portfolio, which includes the innovation of new molecules, discovering new indications, drug design, dosage regimen, the assessment of devices for the administration of drugs, and analyzing the safety of the developed product and determining equivalence against the reference product. The field of Clinical Research involves developing both innovative and generic products, and the criticality of the studies conducted depends upon the type of pharmaceutical formulation, the safety data provided, and the target therapeutic indications.

Regulatory Authorities have specific requirements and expectations from clinical studies when it comes to the safety and efficacy of the innovative molecules and to demonstrate their bio-equivalency with the reference product along with the application of current Good Clinical Practices (GCP). Freyr has a competent team of clinical and Regulatory experts to guide Clinical Research Organizations in Regulatory strategic consulting, Regulatory assessment or gap analysis, as well as to assist in the Compilation and submission of such dossiers to various Health Authorities (HAs). It has expertise in design assistance for clinical studies for innovative and generic molecules customized based on various health authorities' requirements.

"Exclusively focusing on the entire Regulatory value-chain, Freyr leverages its domain expertise and technology innovations to evolve hi-end, next-generation Regulatory solutions and services that enable accelerated performance, operational excellence, and significant cost and compliance benefits to clients."