Welcome. We are Freyr.

Freyr is a full-service global Regulatory Solutions and Services Company and a specialist provider of Regulatory Consulting, Operations & Technology Services.

Freyr exclusively focuses on the entire Regulatory value chain of Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies, globally.

Freyr is a trusted partner providing end-to-end multi-geo, multi-lingual 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 400+ Regulatory Professionals.

QUICK FACTS

Strategic Regulatory Solutions & Services Partner to 6 of the Forbes Global Top 10 Pharma, 3 of the Forbes Global Top 7 Healthcare, 2 of the Forbes Global Top 6 Biotech, 6 of the Top 15 and 20+ Generic, 10+ of the Global Top Medical Device, 50+ Small Medium, CROs, Consulting Firms and Agencies/Standards Authorities.
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    Global Presence US, UK, GERMANY, UAE, MEXICO & INDIA
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    100+ Global Clients and Growing
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    ISO 9001, 27001 Certified, NASSCOM Member
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    Regulatory Services in 120+ Countries
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    400+ Global Regulatory Experts and Growing

REGULATORY SOLUTIONS & SERVICES PORTFOLIO

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    Regulatory Affairs & Operations
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    Regulatory Publishing & Submissions Services
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    Regulatory Intelligence Services
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    Regulatory Labeling & Artwork Services
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    Regulatory Supporting Services
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    Regulatory Strategy & Business Consulting
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    Regulatory Information Management
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    Regulatory Authority Directives

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, operations excellence and significant cost of compliance benefits to clients.

Regulatory Competencies
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Regulatory Operations

  • Submission Management (Electronic, Paper, eCTD, NeeS)
  • Regulatory Dossier Life Cycle Management
  • Labeling & Artwork Management
  • CCDS | Clinical Trial Applications | SPL Submissions
  • Regulatory Data and Document Management
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Regulatory Affairs

  • New Product Introductions & Rollouts
  • CMC Support and Change Control
  • Gap Analysis, MAA, Post Approval Changes
  • Global MA License Renewals
  • Variations Dossier Preparation & HA Responses
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Regulatory Intelligence

  • Primary and Secondary Regulatory Intelligence
  • New Product Development & Launch Strategy
  • New Market and Geography Strategy
  • Actionable Interpretation & Analysis
  • Data Driven, Technology Enabled Decision Support
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Regulatory Information Management & COTS

  • Product Registration Management
  • Quality Data Management
  • Submissions Data Management
  • Product Classifications
  • COTS (Commercial Off-the-Shelf Software)
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Health Authority Mandates

  • FDA - UDI Compliance | Study Data Specifications | CDISC SDTM Data Submissions
  • EU - EVMPD, IDMP & PSMF Compliance | Shelf
    Life Data Submission
  • EU & FDA - ICH eCTD Changing Specifications
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Regulatory Labeling and Artwork

  • Company Core Data Sheet (CDS) / Local Product Labels – Authoring
  • CDS Content & Process Management
  • Clinical and Non-Clinical Overviews
  • Artwork Services & Proof Reading
  • Manuscript Development
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Regulatory Strategy & Business Consulting

  • Regulatory Business Strategy & Consulting
  • Regulatory Centralization
  • Regulatory Process Standardization
  • Regulatory Product & Market Strategy
  • Regulatory Pathways
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Regulatory Software

  • FREYR SOFTWARE: LABEL | SUBMIT | IDENTITY | INSIGHTS | eTMF | EVMPD | rDMS | Drug Info Portal | Product Register
  • THIRD PARTY SOFTWARE: Aris Register, Open Text, Documentum, Liquent Insight Publisher, Lorenz Docubridge, ISI Publisher, eCTD Express, etc..