Jump to navigation
×
Regulatory
Affairs
►
Regulatory
Affairs
◀
New Product Authorization - Finished Products
New Market Authorizations - APIs
Post Approval - CMC and Life Cycle Management
Regulatory Assessment | Gap Analysis
Regulatory Consulting and Strategy
Health Authority Queries – Responses | Interactions
Market Authorization Application (MAA) - Article 10 (1)
MAA - Post-Approval Submissions
MAA - License Renewal
Investigational Medicinal Product Dossiers (IMPD)
Biosimilars MAA – Article 10(4)
Active Substance Master File (ASMF) Submissions
Certification of Suitability (CEP) Submissions
Sister CEP Submissions
Brexit-related Regulatory Support
Dossier Templates for USFDA and EU Regulatory Submissions
Market Access &
Regulatory Intelligence
►
Market Access &
Regulatory Intelligence
◀
Market Access
►
Market Access
◀
Product, Market & Regulatory Pathway Strategy
Regulatory Strategy for Emerging Markets
Regulatory Intelligence
►
Regulatory Intelligence
◀
Drugs Regulatory Intelligence
Medical Devices Regulatory Intelligence
Cosmetics Regulatory Intelligence
Nutraceuticals Regulatory Intelligence
Regulatory Market Intelligence Reports
Health Authority Directives
Freyr Reports
►
Freyr Reports
◀
Regulatory Intelligence
Publishing &
Submissions
►
Publishing &
Submissions
◀
Global eCTD Publishing and Submission Services
NeeS Submissions
Paper Submissions
Legacy Conversions
CSR - Report Level Publishing
Structure Product Labeling/Monograph (SPL/SPM) Submissions
Regulated Product Submissions (RPS)
Drug Master File (DMF) Submissions
Regulatory
Labeling
►
Regulatory
Labeling
◀
Clinical Labeling
Global Labeling
Regional Labeling
►
Regional Labeling
◀
USA
Europe
ROW
►
ROW
◀
TGA’s New Product Information (PI) Format
Labeling Compliance
Medical Devices Labeling
Food/Dietary Supplements Labeling
Regulatory
Artwork Services
►
Regulatory
Artwork Services
◀
Pharmaceuticals
►
Pharmaceuticals
◀
Packaging Artwork Process Consulting
Artwork Lifecycle Coordination
Artwork Management Staffing Services
Artwork Management System PLM Tool
Artwork Proofreading / Quality Check
Artwork RA Labeling
Artwork Studio
Content to Carton
Cosmetics
Food and Food Supplements
Medical Devices
Related
Regulatory Services
►
Related
Regulatory Services
◀
Regulatory Medical Writing
►
Regulatory Medical Writing
◀
Clinical Services
►
Clinical Services
◀
Regulatory Writing Services
Clinical Trial Services
Clinical Trial Audit and Monitoring
Non-clinical Services
►
Non-clinical Services
◀
Nonclinical Regulatory Writing
Permitted Daily Exposure (PDE)
Toxicological Risk Assessment
Safety and PV Services
►
Safety and PV Services
◀
Safety and Pharmacovigilance
Aggregate Report Services/Periodic Safety Report Services
ICSR Services
Signal Detection
Literature Monitoring Services
Periodic Benefit Risk Evaluation Report (PBRER)
Periodic Adverse Drug Experience Reports (PADER)
Quality Control
Compliance, Audit and Validation
►
Compliance, Audit and Validation
◀
GxP Audit Services
SOP Writing and SOP Review Services
Computer System Validation and Computer System Assurance
End-to-End Compliance Services
Remote and Virtual Audit
Industries /
Products
►
Industries /
Products
◀
Pharmaceuticals
►
Pharmaceuticals
◀
Pharmaceuticals Expertise
►
Pharmaceuticals Expertise
◀
Pharmaceuticals
Generics
Innovator Drugs
CRO
CMO
Biologics
Biosimilars
Vaccines
Over-The-Counter Drugs
Our Presence
►
Our Presence
◀
Australia
Austria
Belgium
Canada
China
Czech Republic
Denmark
Egypt
France
Germany
Ireland
Italy
Japan
Malaysia
Netherlands
New Zealand
Poland
Russia
Singapore
Spain
Sweden
Turkey
UK
Ukraine
USA
Medical Devices
►
Medical Devices
◀
Medical Devices Expertise
►
Medical Devices Expertise
◀
Authorized Representative
Labeling & Promotional Material Review
Post Market Surveillance Support
QMS Compliance Services
Regulatory Compliance, Gap Analysis & Remediation
Regulatory Intelligence
Regulatory Strategy
Regulatory Submission and Registration
Translation
510(k) Submission Process Consulting
513(g) Submission Process Consulting
Clinical Evaluation Report (CER)
Medical Devices Regulation (MDR)
In Vitro Diagnostic Regulation (IVDR)
Performance Evaluation Report (PER)
Software as Medical Device Regulatory Support
Our Presence
►
Our Presence
◀
Australia
Brazil
Canada
China
France
Germany
India
Italy
Indonesia
Japan
Malaysia
Mexico
Netherlands
South Korea
Sri Lanka
Taiwan
Thailand
UAE
USA
Vietnam
Cosmetics
►
Cosmetics
◀
Cosmetics Expertise
►
Cosmetics Expertise
◀
Safety Assessment and Toxicology
Research & Development Solutions
Formulation Review and Product Classification
Cosmetics Claims and Substantiation
Labeling Review
Cosmetics Packaging Artwork Solutions
Cosmetics Go-to-Market Services
Product Information / Technical File Compilation
Regulatory Intelligence
Our Presence
►
Our Presence
◀
Australia
Canada
Europe
India
Indonesia
Japan
Malaysia
Mexico
Philippines
Saudi Arabia
South Korea
USA
Food and Food Supplements
►
Food and Food Supplements
◀
Food and Food Supplements Expertise
►
Food and Food Supplements Expertise
◀
Formulation Review and Product Classification
Nutraceuticals Claims Review
Product Labeling Review
Technical Documents/ Dossier Compilation
Nutraceuticals Go-to-Market Services
Freyr iREADY - Ready to Use Ingredients Database
Immunity Boosting Supplements
Novel Food and Novel Food Ingredient Registration
Our Presence
►
Our Presence
◀
Australia and New Zealand
Canada
Europe
India
Japan
South Africa
USA
Vietnam
Chemicals
►
Chemicals
◀
Chemical Toxicological Assessment
Data Scouting Services and Regulatory Intelligence
Poison Center, Chemical Registry, Biocidal Notification/ Registration
Scientific Assessment Reports and Position Paper
Supply-Chain Regulatory Compliance, Formulation Review and INCI List Generation
Regulatory
Software & Services
►
Regulatory
Software & Services
◀
RIM Software
►
RIM Software
◀
Freyr SUBMIT PRO
Freyr rDMS
Freyr iREADY
Freyr IMPACT
Freyr LABEL 360
Freyr IDMP
Freyr SPL/SPM
Freyr XEVMPD
Freyr IDENTITY
Freyr PRISM
RIM Technology & Data Services
►
RIM Technology & Data Services
◀
Master Data Management
►
Master Data Management
◀
IDMP
UDI
Regulatory Software Support
►
Regulatory Software Support
◀
Quality Assurance
Support and Maintenance
Global
Presence
End-to-end
Regulatory Services
COVID-19
PLATFORM
+1 908 483 7958
+44 2037 012379
+1 778 308 4671
+49 6181 707 9007
+52 55 41613365
+65 315 894 72
+603 9212 5527
+91 40 4848 0999
+27 105 002 556
+386 360 004 05
+61 2 8607 5105
sales@freyrsolutions.com
Search
Search this site
Search for
-Any-
Blogs
Careers
Case Studies
Global Presence
News Updates
Newsletters
Products or Softwares
Services
Webinars
Company
About Freyr
Awards & Recognitions
News
Press Releases
Freyr In Media
Industry Events
Testimonials
Careers
Our Culture
Current Openings
Compliance Wall
Corporate Social Responsibility
Resource Center
Blog
Newsletters
Quarterly Newsletter
Monthly Newsletters
Case Studies
100% Accurate MAA and Baseline Submission in Middle East and Switzerland
100% Accurate Submissions to USFDA
100% Accurate and High Quality DMF Submissions in eCTD Format
150+ MA’s successfully Submitted within 1 Month Increasing the Cost Benefits By 50%
24x7 Artwork Creation and Proofing Services in India
24x7 Artwork Creation, Proofreading, And QC Services
24x7 Regulatory Support for LCM Submission
24x7 Regulatory Support for Original NDA Application
24x7 Support with Global Delivery Model to Meet Stringent Deadlines
345, 177 and 198 Submissions for ROW, EU and US Respectively Within 3 Months With 100 % Acceptance
70 Submissions in Three Months with Zero Defect Quality
8000+ Successful Submissions in eCTD Format to Multiple Regions
ANDA and PADER Submissions with Zero Deficiency
Accelerated ASMF submissions in the EU within two weeks
Accelerated AnnexH Report Generation with RIMS Software
Accelerating Ahead Of Competition Delivering Faster Time to Approval
Accelerating the Approval Process for Baseline Submissions
Accurate and Compliant Original IND Filings and Amendments
Artwork Centralization & migration of 11,000 legacy artworks
Artwork Co-ordination and Proofing Services with Quick TAT
Artwork Creation and Technical Review For Successful Indian Market Entry
CAPA, RCA, and Audit Finding Closures within Two Days
CCDS Process Establishment to Audit Preparedness and Support
Closure of External Audit Findings
Collation and Gap Analysis of Regulatory Documentation for Cosmetic
Compilation and Easy Filing of the Variations
Compilation and Preparation of CDS for 80 Products
Compilation and Submission of ANDA as per RTR requirements
Compilation of Clinical Evaluation Report (CER) as per the EU Guidelines
Compilation, review, and submission of amendments Update for 4 products
Complete Review and Compilation of Module 1
Completion of GMP Audits for Two Sites
Compliance Check for Hand Sanitizer in Multiple Markets
Compliant Cosmetic Ingredients Assessment in Japan
Compliant Formulation, Claim and Label Assessment for the US Market
Compliant GMP Audit Services for API Suppliers in Switzerland
Compliant IND Submissions to the USFDA with Quick TAT
Compliant and Accurate Conversion of NeeS Documents into eCTD Format
Comprehensive Gap Analysis and Successful Submission to the USFDA
Comprehensive Gap Analysis of the Labeling Based on 21CFR801
Comprehensive Regulatory Artwork Support with 99.99% Quality Deliverables
Cosmetic Ingredients Assessment as per the CFDA Guidelines
Cosmetics Product Compliance check in Indonesia
Critical Submissions in a Record Time of 1 Day
DMF CTD Conversion and eCTD Publishing for Type II and IV DMFs
Delivered Multi-Country Filings, Staying Ahead Of Guidelines
Development of IND Templates
Device Classification, Regulatory Approach Identification and Registration Services in Mexico
Device Regulatory Strategy and Submission Services in India
EMA Compliant Health Based Risk Assessment (PDE)
EU Claims Support and Notification of Cosmetic Products on CPNP
Effective Health Authority Interactions for 156 Successful Variation Submissions
Enabling Critical Regulatory Market Positioning and Product Launch Strategies
End-To-End Paper to DIN eCTD Submissions In a Single Day, Reducing The Time For Approval
End-To-End Regulatory Services For Registration of Multi-Component and Multi-Variant Devices in India
End-to-End Artwork Process Transition with Zero Recalls
End-to-End Cosmetic Product Compliance Check in Japan
End-to-End Cosmetic Products Notification Services in the EU
End-to-End Device Registration and Market Authorization Holder (MAH) Services in Thailand
End-to-End Gap Analysis of the Raw Data, Compilation and Submission to the USFDA
End-to-End Gap Analysis with Submission of ANDA to the USFDA
End-to-End Implementation of A Validated Document Management System (DMS) for Labeling on OpenText
™
End-to-End Product Compliance Check for Multiple Markets
End-to-End Regulatory Services for ARTG Listing and Australian Sponsor
End-to-End Regulatory Services for Device Registration in Sri Lanka
End-to-End Regulatory Services for Device Registration in the USA
End-to-End Regulatory Services for SaMD Registration with the ANVISA and BRH Support
End-to-end Gap Analysis and consultation for Marketing Authorization Submissions @ SFDA
End-to-end Gap Analysis for IDMP Readiness across Europe
End-to-end Gap Analysis, Compilation of ANDA for Submission to the USFDA
End-to-end Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions
End-to-end Regulatory Support for Legacy Device’s EU MDR Transition
End-to-end Regulatory Support for ODD in the USA
End-to-end Toxicology Risk Assessment services for Perfumes in European Economic Area
Error-Free IND Submissions with Quick TAT
Error-free Artwork Centralization with 50% Cost Savings
Error-free Major Variation Submissions in eCTD format to Australia
Establishing CCDS Process and Preparing for Audit-readiness
Establishing SOPs for QMS/ISMS Remediation
Establishment of Regulatory Affairs Team and Finalization of 40 SOPs
Evaluation and Submission of Response to Information Request
Evaluation and Submission of Response to Screening Deficiency
Expedited Product Classification and NIOSH Certification for N95 Respirator
Expert Opinion on EU GMP Guidelines
Filing Compliant Original Submissions with 100% Accuracy
First successful NDA-Medical Device Submission Made with Reduced Delivery Time from 50 days to 16 Days
First-Time-Right Solution For 99.7% Tasks for UDI Submission
First-time-right Safety Assessment Services Across the Europe
Freyr Deck Regulatory Support for Hand Sanitizer Product Classification in Japan
GCP Audit Services for EU submission in quick TAT
GMP Audit Services for Establishing Management Systems Post-Acquisition
GMP Audit Services with Quick TAT
GMP Audit and Compliance Services
GMP Audit as per the MHRA Guidelines
GMP Audit with End-to-End Gap Analysis
Gap Analysis and Compilation of Design Control Documents
Gap Analysis and Successful submission of ANDA to USFDA
Gap Analysis and review of ANDA as per FDA requirements and RTR
Gap Analysis and technical review of ANDA
Health Supplement Registration/Approval in Malaysia, Indonesia, Vietnam and Philippines
High Quality GMP Audit in Quick TAT
High-Risk Device Registration in Pakistan as per the MDR 2017
Initial Registration of Medical Device and Submission of MDMA
Initial Registration of the Product and Submission to the SFDA
Label Assessment and Claims Review for Oral Care Products in the USA
Label Assessment for Skin and Eye Products in the USA and Canada
Medical Device Classification Support in India (As Per CDSCO)
Mock Audit and Training for Stage II MDSAP Assessment
On Time, Compliant and Accurate Annual Reports Submission
On-Time Submission of DMF Applications in eCTD Format
On-time Delivery of 125 PDE Reports to the MHRA
On-time Delivery of 25 CSR Shells and CSRs
On-time Submission of 10 IBs for Multiple Regions
On-time Submission of Original Applications to the USFDA
One-Time Marketing Status Update to USFDA
Performed Gap Analysis and Successful Submission of ANDA to the USFDA
Performed Gap Analysis with Full Support in Strategy and Preparation of Response to the USFDA
Preparation And Submission of DMF Amendments in eCTD Format to FDA, TPD
Product Correspondence for USA Agent Change
Product Registration and Variation Submissions to 12 African Countries
Publishing and Validation of eCTD Dossier with Successful Submission to the SFDA
QA Consultation Services with Internal QMS for Implementation and Closure of CAPAs
QMS / ISMS Remediation Along with Software Validation
QMS Remediation And Audit Services
QMS Remediation Services Along with End-to-End Gap Analysis
QMS Remediation and Audit Finding Closures in Saudi Arabia
QMS Remediation and Gap-Analysis Services
QMS Remediation and SOP Rationalization for Audit-readiness
QMS Remediation and SOP Rationalization for On-Time Audit Readiness
Quick SOP standardization and Rationalization to Streamline the Processes
Quick TAT for GCP Audit Services
Quick TAT with 100% Accurate ANDA Filings
RI Report on Digital Clinical Trial Data Capture System in the US and EU
Registration of In-Vitro Diagnostic (IVD) Device in Brazil
Regulatory Assessment Report for Cosmetic Ingredients in South Korea
Regulatory Assessment Report on Acceptability of Ingredients in Taiwan
Regulatory Assessment of Ingredients as per the MFDS Guidelines
Regulatory Assistance for Compliant DMF Submissions
Regulatory Compliance for Infant Formula in Malaysia and KSA Markets
Regulatory Framework Report on Approval of Anti-viral Antisera Products in the USA and EU
Regulatory Intelligence (RI) Services for Food Supplements in Europe and Canada
Regulatory Intelligence (RI) Support for Food Labeling Information in the EU
Regulatory Intelligence on PPO Policies in India
Regulatory Intelligence on Stability Studies in Malaysia
Regulatory Services For Listing Newly Regulated Medical Devices in India
Regulatory Strategy and Submission Services
Regulatory Support For Successful PLLR Conversion
Regulatory Support for 24x7 Artwork Services
Regulatory Support for Accelerating Annual Report Submission
Regulatory Support for Audit Services and Inspection Readiness
Regulatory Support for Filing ANDA Applications while Reducing Overall TAT
Regulatory Support for Food Supplements Classification in Canada
Regulatory Support for Ingredient and Label Assessment in the UK
Regulatory Support for Product Compliance, FSSAI License and Import Services in India
Regulatory Support for Submission of Complex CSRs
Regulatory Support for Technology Based Product Classification in the US
Regulatory Support with QA Services
Remote Internal Audit of QMS Systems for 21 CFR 820 and ISO 13485:2016 Compliance
Review and Gap Analysis of Raw Materials Across the EU, JAPAC, Middle East, ROI and ASEAN
Review of Administrative Documents with Successful eCTD Dossier Submission to the SFDA
SOP standardization and Submission of 10 Nonclinical Overviews
Saved Over 60% in Cost of Compliance and 360 Man Hour Effort
Saved Over 60% in Cost of Compliance and 360 Man Hour Effort
Streamlining the Assessment Process for PLLR Category Removal
Submission of CBE 30 within 3 days
Submission of DMF for Genomic Assay Method to USFDA
Successful 50+ SPL Submissions In 20 Days
Successful ANDA Filing with zero deficiency
Successful ANDA Submission to the USFDA with End-to-End Gap Analysis
Successful ANDA and DMF Submissions to the USFDA and Health Canada
Successful ANDA and DMF Submissions with Increased Cost-Benefits
Successful Artwork Updation with 99.99% Quality of Delivery
Successful Authoring of 45 Protocols and Protocol Amendments
Successful Authoring of 60+ Submission Ready ICFs
Successful BLA Submissions with Zero Deficiencies for US Region
Successful Baseline Paper to eCTD submissions to GCC Oman
Successful Change of RP and the Product Re-notification in the EU
Successful Classification & Registration of Medical Device in Vietnam
Successful Classification & Registration of Medical Device in the US and EU
Successful Classification & Registration of Medical Device with the TFDA
Successful Classification of Medical Device as per the Regulations of CDSCO
Successful Classification of a Cosmetic Product in Multiple Markets
Successful Compilation And Submission Of The Annual Report 2018
Successful Compilation and Submission of CSR in 7 Days
Successful Completion of 4 High Quality CSR Publishing in Short TAT
Successful Completion of GMP Audits within 2 Weeks
Successful Completion of NMC Meeting with COFEPRIS
Successful Conversion of 17 Existing DMFs into eCTD
Successful Conversion of 37 DMFs into eCTD Format
Successful Conversion of Type II DMFs into eCTD Format
Successful DIN Submissions in eCTD format to Health Canada
Successful DMF Conversion to eCTD and Submission to the USFDA
Successful DMF Filings in the USA and Canada
Successful DMF Submission to the USFDA with Zero Deficiency
Successful DMF submission to the Health Canada
Successful DMF submissions within one week that yielded 70% cost benefits
Successful Delivery of 30+ Protocols in less than 10 Business Days
Successful Delivery of Error-Free IND Submissions
Successful Delivery of High Quality NDA Applications
Successful Delivery of Scientific Validity Reports (SVRs) for 11 IVDs
Successful Execution of More Than 250 Clinical Trials across Locations
Successful Execution of Validation Procedure
Successful Filing of DMF and Amendments in the USA
Successful GMP Audit Services Avoiding Potential Non-conformances
Successful GMP Audit Services at Manufacturing Facilities
Successful GMP Audit with necessary suggestions and recommendations
Successful Global Regulatory Assessment and Roadmap Preparation
Successful GxP Audit for 15+ CROs under Short Timelines
Successful IND Filings in the US Region
Successful IND Submission in 4 Weeks saving 70% on Cost of Compliance
Successful IND and NDA Submission to the USFDA
Successful Identification of Medical Device Category in the EU Region
Successful Ingredient Assessment as per the USFDA’s Guidelines
Successful LCM Submissions and Validation with Freyr SUBMIT PRO
Successful MAA Filings with Zero Deficiency
Successful Management of Product Registrations with Freyr PRISM
Successful Medicinal Product Registration in Indonesia
Successful NDA - Medical Device Submission in Reduced Delivery Time frame (from 50 days to 16 Days)
Successful Preparation and Submission of 15+ IBs
Successful Product Classification & Compliance Check of an FSDU in India
Successful Registration of Mobile Medical App in the US and EU region
Successful Regulatory Artwork Support During M&A Within 3 Months
Successful Regulatory Support For DMF, ANDA Pre- and Post- Approval Activities
Successful Regulatory Support for A Technical Change with COFEPRIS
Successful Regulatory Support for Regional Labeling Operations and Process Improvement
Successful Regulatory Support for SPL submissions within two weeks
Successful Review of the Packaging Labels, Impact Analysis, and Submission to the USFDA
Successful Review of the Raw Data, Compilation and Submission to the USFDA
Successful SPL Submission in 2 Weeks, Increasing 50% in Cost of Compliance Benefits
Successful Submission of 80 CDS and Clinical Overviews
Successful Submission of 8000+ High Quality Applications
Successful Submission of Annual Reports in eCTD Format
Successful Submission of DMF and Annual Report in the US Region
Successful Submission of High Quality CEP Applications
Successful Submission of IND Applications and Amendments to the USFDA
Successful Submission of Original Application with Zero Deficiency