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Medicinal Products Regulatory Services
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MPR - Regulatory Operations Menu
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MPR - Pharmacovigilance Menu Block
Medical Literature Monitoring
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CE Marking
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Clinical Evaluation
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Document Management
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Regulatory Artwork

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Regulatory Mergers & Acquisition Services
Device Documentation
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Modernization of the Cosmetics Regulation Act of 2022 (MoCRA)
Go-to-market and Legal Representative (LR)
EUDR Compliance Services for Cosmetics Industry

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Claims Review, Substantiation, and Notification Support
Food and Food Supplement Classification: A Global Overview
Manufacturing Facility Registration Support (FFR/FBO/Site license)
Labeling Compliance
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Food Product Registration Service/Notification
Legal Representation (LR) Support
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Categories Supported
Cultured Food Products Regulatory Compliance for (Animal & Plant-Based)
Dietary Supplement Regulation and Compliance
Ensure Global Compliance for Your Tobacco and Nicotine Products
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Infant Formula Regulatory Compliance
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Recycling Logo Content and Design Support for Food and Food Supplements
Navigate EPR, PCR, PPWR & SUP Compliance with Confidence!
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Global Regulatory Intelligence
CSRA - Chemicals service1 Menu
Extended Safety Data Sheet (eSDS) Services
Global Regulatory Compliance and Consulting (GRCC)
Chemical Data Scouting
Chemical Scientific Assessment Reports and Position Paper Report
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Chemical Packaging Regulations
Global Biocidal Products Regulation Services
Regulation of Tobacco Products
Ecolabeling Regulatory Support
Chemical Safety Data Sheet (SDS) Authoring & Compliance Services
Household and Chemical Products Artwork Services
Sustainability Consulting Services

CSRA - Chemicals service2 Menu
Pet Care Products Registration
General Product Safety Regulation (GPSR)
Global REACH Regulatory Compliance
Chemical Toxicological Risk Assessment
EUDR Compliance Services for Chemical & general consumer product
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Global Regulatory Intelligence
EU Poison Centre Notification (PCN)
EU Detergents Regulation (EU) 2026/405
LHAMA Compliance Services: US Art Materials Regulation & ASTM D-4236 Compliance

EUDR Compliance | Food, Cosmetics & Chemicals
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Freya Fusion
Via: Variation Identification 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
Consumer
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Regulatory Affairs Services
Market Access with end-to-end Regulatory Solutions
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Pre-submission Meetings/HA Interactions
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Clinical Labeling
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Developmental CCDS Creation & Updation
Labeling Automation
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Labeling Templatization
Large-volume Change Automation
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e-labeling
AI-powered Regulatory Labeling Services
Pharma Labeling Compliance
Regulatory Artwork Solutions
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Artwork Graphic Studio
Packaging Artwork Mock-up Creation
Changes to Existing Artwork
Private Label Artwork for Pharma
Artwork Proofreading
Global Artwork Translation
Artwork Process Consultancy
Printed Packaging Print-Proof Quality Check
Content to Carton
Artwork Lifecycle Coordination
End-to-End Artwork Workflow Coordination
Pharmacovigilance
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
Qualified Person for Pharmacovigilance
Regulatory Intelligence in Pharmacovigilance
Pharmacovigilance (PV) Safety Database Services & Solutions
Medical Writing
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Clinical Trial Audit and Monitoring Services
Quality Check and Medical Review of Regulatory Documents
Risk-Benefit Analysis
Clinical Data Transparency Initiative
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ADE/PDE Determination/Report Services
F-Value Reports for Child Resistant Packaging (CRP)
Toxicological Risk Assessment (TRA) of Impurities, Extractables and Leachables
Environmental Risk Assessment (ERA) of Medicinal Products
Clinical and Non-Clinical Consulting and Strategic Services
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
Literature review tool
Quality review tool
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
USFDA
Abbreviated New Drug Application
ANDA Refuse-to-Receive Practices
Due Diligence Assessment of ANDA
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
US FDA Query Management (IRs/ DRLs/ CRLs)
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
Renewals Submissions
Gap Analysis and Authoring
Publishing and Submission
Change Control Evaluation and Variation Submission Strategies
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 Anfragenmanagement
Unsere Kompetenzen
Sicherstellung der „richtigen Gelegenheiten“ für den „richtigen Markt“
Bewältigung komplexer regulatorischer Herausforderungen bei Generika
Fachwissen für Generika-Anträge
Drug Master File (DMF) Einreichungen Expertise
Generika für die erste Einreichung
FAQs zu Generika
Innovatoren
Unsere regulatorischen Dienstleistungen
Antrag auf Zulassung biologischer Arzneimittel (BLA)
Anträge für klinische Studien (CTAs)
Investigational Medicinal Product Dossier
Investigational New Drug Applications
Anträge für neue Arzneimittel
Einreichungen für neue Arzneimittel
Funktionsübergreifende Spezialisierung
Clinical Labeling
Überwachung klinischer Studien
DMF Kompetenzen
Toxikologische Risikobewertung
Kompetenzen für Publikation und Einreichung
Kompetenzen für regulatorische Kennzeichnung
Kompetenzen für regulatorisches medizinisches Schreiben
Kompetenzen für die Beratung zur regulatorischen Strategie
Artwork-Kompetenzen
Regionale Expertise
Regionale Expertise
Freyr als Partner ab der Entdeckungsphase
Freyr als Partner ab der Entdeckungsphase
Medizinprodukte
Marktzugang
Geräteregistrierung Amerika
USA
e-Star
513(g)
510(k)
Q-submission
Zulassung vor Markteinführung
RFD & Pre-RFD
UDI- und GUDID-Lösungen für die FDA-Konformität
Kanada
ISED-Vertretungsdienstleistung für Kanada
Lösungen für die Betriebslizenz für Medizinprodukte (MDEL) in Kanada
Lösungen für Importeure von Medizinprodukten zur Einhaltung der Vorschriften in Kanada
Lösungen für die Medizinproduktlizenz (MDL) in Kanada
Geräteregistrierung Europa
CE-Kennzeichnung
EU MDR
EU IVDR
Europäischer Bevollmächtigter
Geräteregistrierung China
Geräteregistrierung Südkorea
Geräteregistrierung Australien
Geräteregistrierung UK
Geräteregistrierung Schweiz
Geräteregistrierung: Rest der Welt
Lokale Vertretung
Australischer TGA-Sponsor
Koreanischer Registrierungsinhaber (KRH)
Mexikanischer Registrierungsinhaber (MRH)
US-Bevollmächtigter
Schweizer Bevollmächtigter (CH-Rep)
Verantwortliche Person im UK (UKRP)
Benannter Zulassungsinhaber (DMAH)
Vertretungsdienstleistungen für China
Brasilianischer Registrierungsinhaber (BRH)
Indischer Bevollmächtigter Agent für die Medizinprodukte-Registrierung in Indien
Vertretung im Land – Rest der Welt
Post-Market Surveillance
Beschwerdebearbeitung für Medizinprodukte
PMS-Plan (PMSP) und PMS-Bericht (PMSR) für Medizinprodukte
Periodischer Sicherheitsbericht (PSUR) für Medizinprodukte und IVDs
Management von Rückrufen von Medizinprodukten
Bewertung von Gesundheitsrisiken
Übersetzungsdienstleistungen für Medizinprodukte
Medizinisches Schreiben für Medizinprodukte
Klinische Bewertung
Klinischer Bewertungsplan (CEP)
Klinischer Bewertungsbericht (CER)
Leistungsbewertung
Bericht zur wissenschaftlichen Validität (SVR)
Bericht zur klinischen Leistung (CPR)
Bericht zur analytischen Leistung (APR)
Leistungsbewertung für In-vitro-Diagnostika
Leistungsbewertungsbericht (PER) IVDR
Lifecycle Management
Protokoll und Überprüfung der Literaturrecherche
Regulatory Affairs
Regulatorische M&A-Dienstleistungen
Produktdokumentation
Geräteakte
Veröffentlichung der technischen Akte für Medizinprodukte
Kennzeichnungsdienstleistungen
Technische Redaktionsdienstleistungen
RA Dienstleistungen zur Personalaufstockung
Regulierungsberatung
Lebenszyklusmanagement
Beratung zu Medizinprodukten
IVD-Beratung
SaMD Beratung
Kombinationsprodukte-Beratung
Regulatorische Intelligenz
Klassifizierung und Einstufung von Medizinprodukten
Human Factors Engineering für Medizinprodukte
Marktinformationsdienst
Medical and Scientific Communication
Dienstleistungen im Bereich Biokompatibilität für Medizinprodukte
Qualitätsmanagementsystem (QMS)
Beratungsdienstleistungen im Bereich Qualitätsmanagement
ISO 14971 Risikomanagement-Beratung
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