Freyr is one of the largest, global, Regulatory-focused solutions and services companies for the Life Sciences industry, supporting Large, Medium, and Small size global Life Sciences companies (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare: Cosmetics | Food Supplements | Chemicals) 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. Freyr is also expanding its footprints into other key areas like Pharmacovigilance. One of the Largest, Global, Regulatory-focused Solutions and Services Companies Freyr has grown to be a trusted Regulatory partner to 1100+ global customers, including 8 of the Global Top 10 Drugs and Biotechnology Companies, 4 of the Top 10 Med Tech and Healthcare Equipment and services companies, 2 of the Global Leading COVID Vaccine companies, 5 of the Global Top 10 Household & Personal Products Companies, and 2 of the Top 10 Food & Drinks Companies, and 100s of Mid-market $1+ Billion BioPharma, and Several Small and Medium, Fast Growing Life Sciences companies, CROs, and Standards Agencies. Freyr has pioneered specialized Centers of Excellence (CoEs) exclusively focusing on the entire Regulatory value-chain supported by rapidly growing 1600+ In-house Regulatory Professionals. Quick Facts Strategic Regulatory Solutions & Services Partner to 8 Forbes Global Top 10 Drugs & Biotechnology Companies 4 Forbes Global Top 10 Health Care Equipment & Services 3 Forbes Global Top 10 Household & Personal Product Companies 2 Forbes Global Top 10 Chemicals Companies 2 Forbes Global Top 10 Food & Drink Companies 130+ Innovator Pharma Companies 50+ Bio-Tech/Bio-Similar Companies 135+ CROs/Consulting Companies 1100+ Customers 260+ Medical Device Companies 350+Consumer Companies(Cosmetics/Food and Food Supplements) 175+Generic Companies/API Manufacturers Global Presence USA, UK, Canada, Germany, UAE, Mexico, Singapore, Malaysia, South Africa, Sri Lanka, Slovenia, Poland, Australia, France, Switzerland, China, Japan, Brazil & India (Global Delivery Center) ISO 9001 and ISO 27001 Certified 950+ In-country Regulatory AffiliatesAcross 120+ Countries 1600+ In-house 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 Pharmacovigilance Mergers & Acquisitions 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 Pharmacovigilance Pharmacovigilance is one of the most important functions within Life science companies. Pharmacovigilance (PV), also known as Drug Safety, relates to two (02) major aspects of any drug formulation/medical intervention with therapeutic benefit, safety, and efficacy. The first is to know whether a drug works, and the second is to decode safety. Know More Mergers & Acquisitions At Freyr, our Regulatory Strategy Consulting team understands the ins and outs of the pre-, during, and post- transition processes. Our SoMAD segment serves as a Transition Management Office, while the companies work on establishing their new identity. Know More
