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.
REGULATORY SOLUTIONS & SERVICES PORTFOLIO
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.
- 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
- New Product Introductions & Rollouts
- CMC Support and Change Control
- Gap Analysis, MAA, Post Approval Changes
- Global MA License Renewals
- Variations Dossier Preparation & HA Responses
- 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
- 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..