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EUDR Compliance | Food, Cosmetics & Chemicals
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Freya Fusion
Via: Variation Identification Agent
Ria: Regulatory Impact Assessment Agent
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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End-to-End Artwork Workflow Coordination
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Medical Literature Monitoring
Individual Case Safety Report
Aggregate Safety Reports
Pharmacovigilance Risk Management Plan
Pharmacovigilance (PV) Signal Detection Services
Pharmacovigilance (PV) Audit Services
Quality Control in Pharmacovigilance
QPPV and LPPV Services for Global PV Compliance
Regulatory Intelligence in Pharmacovigilance
Safety Database Solutions for Compliant PV Data Management
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QC and Medical Review for Accurate Regulatory Documents
Risk-Benefit Analysis
Clinical Data Transparency Initiative
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F-Value Reports for Child Resistant Packaging (CRP)
Toxicological Risk Assessment (TRA) of Impurities, Extractables and Leachables
Pharmaceutical Environmental Risk Assessment (ERA) Services
Expert Clinical and Non-Clinical Regulatory Consulting
Clinical Writing Consulting and Strategic Services
Technical Writing Support for GxP Compliance
Business Process Optimization
Non-clinical Consulting & Strategic Services
Automation in Medical Writing
Narrative writing tool
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End-to-End Medical Writing Services
Compliance and Audit Services
Pharma Quality and Compliance Services
SOP Writing and SOP Review Services
Pharma GxP Audit Services
Remote and Virtual Audits
Pharma CSV and CSA Services
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
Pre-ANDA Submissions
Competitive Generic Therapies Designation
Product Development Strategy for Generic Drug
ANDA Post-approval Changes
Drug Master File (DMF) Submission
Change Control Assessment and Change Submission Strategy
ANDA Pre-Submission Facility Correspondence
Gap Analysis and Authoring
Publishing and Submission
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EU- EMA
MAA Approval Support
MAA Registration
Health Authority Interactions in Europe
ASMF/CEP Submissions
Post-approval Changes to Drug Substance
MAH/QP/QPPV Requirements
Sunset Clause
Submission Slot Booking
Hybrid Applications
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Gap Analysis and Authoring
Publishing and Submission
Change Control Assessment and Variation Filing for Generics
Health Canada
Regulatory Strategic Guidance
Health Canada ANDS
Health Canada Drug Master File (DMF) Submission
Change Control Evaluation and Submission Strategy
ANDA Post-approval Change Submissions
Canada Health Authority Interactions
Health Canada Query Management
Our Capabilities
Ensuring 'Right Opportunities' for 'Right Market'
Breaking complex generics Regulatory Challenges
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First-to-File Generics
FAQs on Generics
Innovators
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Biologics License Application (BLA)
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DMF Capabilities
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Publishing and Submission Competencies
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Regional Expertise
Freyr as a Partner from Discovery Stage
Freyr as a Partner from Discovery Stage
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510(k)
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Medical Device Importer Solutions for Compliance in Canada
Medical Device Licence (MDL) Solutions for Canada
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CE Marking
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Device Registration Australia
Device Registration UK
Device Registration Switzerland
Device Registration: Rest of the World
In-Country Representation
Australian TGA Sponsor
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Mexican Registration Holder (MRH)
US Agent
Swiss Authorised Representative (CH-Rep)
UK Responsible Person (UKRP)
Designated Market Authorization Holder (DMAH)
China Agent Services
Brazil Registration Holder (BRH)
Indian Authorization Agent for Medical Device Registration in India
In-country representation Rest of the world
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
Clinical Evaluation Plan (CEP)
Clinical Evaluation Report (CER)
Performance Evaluation
Scientific Validity Report (SVR)
Clinical Performance Report (CPR)
Analytical Performance Report (APR)
Performance Evaluation for In Vitro Diagnostic Medical Devices
Performance EvaluationReport (PER) IVDR
Lifecycle Management
Literature Search Protocol and Review
Regulatory Affairs
Regulatory Mergers & Acquisition Services
Device Documentation
Device History File
Device Technical File Publishing
Labeling Services
Technical Writing Services
RA Staff Augementation Services
Regulatory Consulting
Life cycle management
Medical Device Consulting
IVD 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)
Cosmetic Product Formulation and Ingredient Review
Cosmetic Product Information File Services (PIF)
MoCRA Compliance Services & FDA Cosmetic Registration Support
Go-to-market and Legal Representative (LR)
EUDR Compliance Services for Cosmetics Industry
Cosmetics Service
Comprehensive Artwork Services for Cosmetics
Global Cosmetovigilance 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)
Novel Food Regulation Compliance
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FDS1

NOVEL Food & New Dietary Ingredient Registration/ Notification

NDIN and GRAS to USFDA (New ingredient)

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Food Supplements

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