Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions. A Global Regulatory Solutions & Services Company Freyr is a trusted partner, providing end-to-end Regulatory services, across Top 20 global brands for 6 of the Forbes* Global Top 10 Fortune 500 Healthcare / Life Sciences, Mid-market $1+ Billion Bio Pharma, and Several Small-Medium, Fast Growing Life Sciences companies, CROs and Standards agencies. Freyr 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 550+ Regulatory Professionals. Quick Facts Strategic Regulatory Solutions & Services Partner to 250+ Clients 7 Forbes Global Top 10, Pharma Companies 5 Forbes Global Top 6, Biotech Companies 5 Forbes Global Top 7, Consumer Healthcare Companies 6 Top 15 and 20+, Generic Companies 30+ Innovator Pharma Companies 10+ Bio-Tech / Bio-Similar Companies 10+ CROs / Consulting Companies 30+ Medical Device Companies 35+Consumer Companies (Cosmetics / Nutraceuticals) 50+Generic Companies / API Manufacturers Global Presence USA, UK, CANADA, GERMANY, UAE, MEXICO, SINGAPORE, MALAYSIA, SOUTH AFRICA, SLOVENIA & INDIA(Global Delivery Center) ISO 9001 and ISO 27001 Certified Regulatory Services in 120+ Countries 550+ Global Regulatory Experts and Growing Regulatory Competencies 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. Regulatory Affairs Market Access & Regulatory Strategy Publishing & Submissions Regulatory Labeling Artwork Pack Management Regulatory Medical Writing Compliance & Validation Services Regulatory Software Regulatory Affairs Comprehensive Regulatory affairs for new product and market authorizations, Health Authority submissions, post-approvals, CMC and lifecycle management. Know More Market Access & Regulatory Intelligence Enabling Life Sciences organizations reach global markets with impeccable product, market and Regulatory pathway strategies, Regulatory intelligence, and enterprise process consulting. Know More Publishing & Submissions Streamlining entire publishing and submission management process right from planning, dossier development, tracking, publishing, submissions and delivery confirmation/acknowledgement. Know More Regulatory Labeling End-to-end labeling services and software support for global and regional labeling management, CCDS creation and updation, core to local label alignment etc. Know More Artwork Pack Management Innovative, and cost-effective Regulatory artwork design & pack management services and software to support new product launches and brand re-designs. Know More Regulatory Medical Writing World-class Regulatory and medical writing services to put across scientific and clinical information in a clear, concise and compliant way. Know More Compliance & Validation Services Specialized GxP audit, QMS Remediation, Process and Product Validation and GxP Solution consulting services to assist Life Sciences organizations comply with Health Authority requirements. Know More Regulatory Software Freyr offers complete suite of Regulatory tools and software services that match to client requirements; be it publishing and submissions, labeling, Regulatory intelligence, Regulatory document management, trail master files, IDMP, and end-to-end UDI compliance solution. Know More
