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Freya Fusion
Via: Variation Identification Agent
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Stay Ahead with a Unified, AI-First Regulatory Cloud
freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs. Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML. freya fusion is a unified ecosystem that empowers RIM and covers the entire regulatory lifecycle - from registrations and submissions to labeling, artwork, intelligence, and change control. Know More
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Individual Case Safety Report
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Pharmacovigilance Risk Management Plan
Pharmacovigilance (PV) Signal Detection Services
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Quality Control in Pharmacovigilance
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Remote and Virtual Audits
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QMS Remediation and Establishment Services
End-to-end Regulatory Compliance Services
Medical and Scientific Communication
Medical Copywriting Services
Medical and Scientific Writing Services
Medical and Scientific Publication Services
Creative Scientific Design Studio
Promotional Materials MLR Review
Medical and Scientific Content Management
FDA Ad Promo Submission Services - OPDP 2253
Global Regulatory Intelligence
Global Regulatory Intelligence
Generics
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US FDA Health Authority Interactions
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Product Development Strategy for Generic Drug
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Drug Master File (DMF) Submission
Change Control Assessment and Change Submission Strategy
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EU- EMA
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MAA Registration
Health Authority Interactions in Europe
ASMF/CEP Submissions
Post-approval Changes to Drug Substance
MAH/QP/QPPV Requirements
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Regulatory Strategic Guidance
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Change Control Evaluation and Submission Strategy
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Canada Health Authority Interactions
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Freyr as a Partner from Discovery Stage
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Post Market Surveillance
Medical Device Complaint Handling
PMS Plan (PMSP) and PMS Report (PMSR) for Medical Devices
Periodic Safety Update Report (PSUR) for Medical Devices and IVDs
Medical Device Recall Management
Health Hazard Evaluation
Medical Device Translation Services
Post-Market Clinical Follow-Up (PMCF) for Medical Devices
Medical Writing for Medical Devices
Clinical Evaluation
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Clinical Performance Report (CPR)
Analytical Performance Report (APR)
Performance Evaluation for In Vitro Diagnostic Medical Devices
Performance EvaluationReport (PER) IVDR
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Device Documentation
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Labeling Services
Technical Writing Services
RA Staff Augementation Services
Regulatory Consulting
Life cycle management
Medical Device Consulting
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SaMD Consulting
Combination product Consulting
Regulatory Intelligence
Device classification & Categorization
Human Factors Engineering for Medical Devices
Market Intelligence Service
Medical and Scientific Communication
Biocompatibility Services for Medical Devices
Quality Management System (QMS)
QMS Consultancy Services
ISO 14971 Risk Management Consulting
QMS Remediation for Medical Devices
QMS Compliance and Audit Services
Document Management
Corrective and Preventive Action Management Services
Supplier Evaluation
Digital Health/SaMD
SaMD Registration in the US
SaMD Registration in the EU
Global Market Expansion for SaMD
Regulatory Strategy Consultation for SaMD
Quality Management Systems Implementation
Artwork Services
Regulatory Artwork
Global Regulatory Intelligence
Global Regulatory Intelligence
Cosmetics
Cosmetics Services
Cosmetic Product Labeling Review
Cosmetic Safety Assessment and Toxicology Services
Global Regulatory Compliance and Consulting (GRCC)
Formulation and Ingredient Review
Cosmetic Product Information File (PIF)
Modernization of the Cosmetics Regulation Act of 2022 (MoCRA)
Go-to-market and Legal Representative (LR)
EUDR Compliance Services for Cosmetics Industry
Cosmetics Service
Comprehensive Artwork Services for Cosmetics
Global Cosmetovigilence Services
Claims Review
Cosmetic Testing Services
Cosmetic Regulatory Intelligence
Global Regulatory Intelligence
Food Supplements
Food & Food Supplements Product Services
Food & Food Supplements Product Services
Food and Food Supplements Artwork Services
Global Regulatory Compliance and Consulting (GRCC)
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