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.


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.
    Global Presence US, UK, GERMANY, UAE, MEXICO & INDIA
    100+ Global Clients and Growing
    ISO 9001, 27001 Certified, NASSCOM Member
    Regulatory Services in 120+ Countries
    400+ Global Regulatory Experts and Growing


    Regulatory Affairs & Operations
    Regulatory Publishing & Submissions Services
    Regulatory Intelligence Services
    Regulatory Labeling & Artwork Services
    Regulatory Support Services
    Regulatory Strategy & Business Consulting
    Regulatory Information Management
    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

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

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

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

Regulatory Information Management & COTS

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

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

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

Regulatory Strategy & Business Consulting

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

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..