A U.S. based pharmaceutical client approached Freyr for the submission of withdrawal of ANDA to the USFDA and payment of facility fee as per Generic Drug User Fee Amendments (GDUFA).
Read this case to know how Freyr carried the entire process.
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- 25 PLLR Conversions for Generics
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- 50+ SPL Conversions and Submissions with the USFDA
- 70 Submissions in Three Months with Zero Defect Quality
- 8000+ Successful Submissions in eCTD Format to Multiple Regions
- ANDA Annual Report Preparation Within Agreed Timelines
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- ANDA Submission with Zero Deficiencies
- ANDA and PADER Submissions with Zero Deficiency
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- Authoring 70+ PADER Reports with Considerable Cost Benefits
- Authoring 70+ PADER Reports with Considerable Cost Benefits
- Authoring of 80 Core Data Sheets for Established Medicinal Products
- Baby Skin Care Products’ Compliance Check for Multiple Markets
- CAPA, RCA, and Audit Finding Closures within Two Days
- CCDS Process Establishment to Audit Preparedness and Support
- CGT Request Preparation and Submission to the US FDA
- Calculation of Health Based Exposure Limits (PDE/OEL)
- Calculation of Health Based Exposure Limits (PDE/OEL)
- Calculation of Health Based Exposure Limits (PDE/OEL)
- Calculation of Health Based Exposure Limits (PDE/OEL)
- Calculation of Health Based Exposure Limits (PDE/OEL)
- Claims Assessment for Oral Care Products In Malaysia
- 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 Hair Care Products In Malaysia
- Compliance Check for Hand Sanitizer in Multiple Markets
- Compliant ANDA Submission under Stringent Timelines
- 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 Annual Reports Preparation and Publishing for Multiple Products
- DMF CTD Conversion and eCTD Publishing for Type II and IV DMFs
- Delivered Multi-Country Filings, Staying Ahead Of Guidelines
- Developing and Adopting Best Practices Based on Core & Country Labeling Requirements
- 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 Notification Services for Malaysia
- 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 Cosmetics in Australia
- End-to-End Product Compliance Check for Multiple Markets
- End-to-End Regulatory Assistance for ANDA Registration
- End-to-End Regulatory Intelligence Services for Cosmetic Products in India
- 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 Registration Services For High-risk Devices in Thailand
- End-to-end Regulatory Services for Market-Entry of IVD Products in African Countries
- 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 DMF Submissions to US FDA
- 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
- Freyr SUBMIT PRO for Compliant eCTD Submissions
- 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
- GPvP Audit in LATAM Region
- Gap Analysis and Authoring of ANDA Supplement Package
- 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
- Global Label Management Support For 320 Products
- Global Labeling Management, Technology Consulting and Implementation
- GxP Audit of Vendor Facilities in France
- Handling of Discipline Review Letter (DRL) for ANDA to the USFDA
- Health Supplement Registration/Approval in Malaysia, Indonesia, Vietnam and Philippines
- High Quality GMP Audit in Quick TAT
- High-Quality Original IND Submission with 100% Accuracy
- High-Risk Device Registration in Pakistan as per the MDR 2017
- Implementation of CDPM Functions for 395 CRRs with 50% Cost Savings and Zero Recalls
- 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 Cosmetics in Japan
- Label Assessment for Skin and Eye Products in the USA and Canada
- Labeling Compliance Services for New MAAs
- Labeling Services for Radiology Devices
- Literature Review and Literature Summary Report
- Medical Device Classification Support in India (As Per CDSCO)
- Medical Device Registration and Authorized Representative (AR) Support in Malaysia
- Medical Writing Services for Updating Clinical Evaluation Report (CER) and Compilation of Periodic Safety Update Report (PSUR)
- Meeting Regulatory Requirements for Core and Regional Labeling Compliance
- Mock Audit and Training for Stage II MDSAP Assessment
- Multi-device Registration with the TGA, and Australian Sponsor Services
- Multi–country Device Registration and License Holding Services for Orthodontic Devices
- NeeS to eCTD Conversions and DLP & SLP Activities
- NeeS to eCTD Conversions for Multiple Products
- On Time, Compliant and Accurate Annual Reports Submission
- On-Time Submission of DMF Applications in eCTD Format
- On-time BLA Submissions to US FDA
- 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
- On-time Submission of Q5 PADER to the US FDA
- One-Time Marketing Status Update to USFDA
- Original IND and Amendment Submissions with 100% Accuracy
- PDE Calculation Report Services
- PLLR Category Removal for 218 USPIs
- 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
- Preparation and Submission of Response for ANDA to the US FDA
- Preparation of Non-Clinical Overviews
- Preparation of PADER Reports Under Short Timelines
- Product Compliance Check for Complementary Medicines in Australia
- Product Compliance Check for Dietary Supplements in the USA
- Product Compliance Service for Food Products in Canada
- Product Compliance Service for Food Supplements in the United Kingdom
- Product Compliance Services for Health Supplements in Singapore
- Product Correspondence for USA Agent Change
- Product Registration and Variation Submissions to 12 African Countries
- Proven Labeling Expertise for USPI, PIL Creation, Review, and SPL Review
- 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
- Quality CSR Submissions within Reduced Turnaround Time (TAT)
- 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 CCDS Update and Reporting Process
- Regulatory Assistance for Compliant DMF Submissions
- Regulatory Compliance for Infant Formula in Malaysia and KSA Markets
- Regulatory Compliant eCTD Submission with Freyr SUBMIT PRO
- 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) Services for Multiple IVDs for Multiple Countries
- Regulatory Intelligence (RI) Support for Food Labeling Information in the EU
- Regulatory Intelligence (RI), Device Registration and Authorized Representative Services for SaMDs
- Regulatory Intelligence Service for Cosmetic Products in Kenya
- Regulatory Intelligence for Food Products and Health Supplements in Singapore
- Regulatory Intelligence on PPO Policies in India
- Regulatory Intelligence on Stability Studies in Malaysia
- Regulatory Report on Water Solubility Test Protocol
- Regulatory Services For Listing Newly Regulated Medical Devices in India
- Regulatory Services for Medical Device Registration and LR Support in Thailand
- Regulatory Services for Notification of a Medical Device in Thailand
- Regulatory Services for Registration of Low Moderate Risk 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 Creation of Annual Summary Reports - CASR
- Regulatory Support for DMF Filing with the US FDA and Health Canada
- 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 CCDS Management and HA Audit Support
- 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 Health Canada
- Successful DMF Submission to the USFDA with Zero Deficiency
- 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 Establishment of Audit-ready Processes And Management Systems
- 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 SPAR
- 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 Preparation and Submission of IND Annual Report
- Successful Product Classification & Compliance Check of an FSDU in India
- Successful Registration of Mobile Medical App in the US and EU region
- Successful Registration of Respiratory Devices with the CDSCO
- 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
- Successful Submission of Zero Deficiency IND Applications
- Successful Submissions with Zero Deficiency and 100% Accuracy
- Successful Type III DMF Compilation and eCTD Submission to USFDA
- Successful and 100% Accurate IND Submissions to the USFDA
- Successful and Timely Delivery of 10000+ Pages of IND Submission
- Successful and Valid IND Submission with Swift Approvals
- Successful eCTD Dossier Preparation and Submission to the SFDA
- Successful filing of 5 variations & re-formatting of the complete dossier
- Successful preparation of CTD modules and submission of ANDA to USFDA
- Successfully Completed 200 Studies in a Reduced Delivery Time from 2 Months to 5 Days
- Successfully Provided In-Depth Market Intelligence Insights across 7 SSA Countries
- Support for the withdrawal of the ANDA to be eligible under GDUFA
- TGA Compliant Product Information (PI) Labeling Services
- Technical Review and Submission of ANDA to the USFDA
- Technical Review of BMR in accordance with USFDA
- Technical Support for Response Document Formatting and Submission to the Health Canada
- Technical Support for Submission of 2 DMFs in eCTD
- Time-critical Audit Services For Significant Cost Savings
- Timely Compilation and Submission of Annual Report for NPH Opth to the USFDA
- Timely Compilation and Submission of Annual Report for NPH Otic to the USFDA
- Timely NDA Submission with Zero-Errors
- Timely Preparation and Evaluation of 250 PDE
- Timely Provision of Regulatory Staffing Services for Regulatory Affairs, Operations, XEVMPD, Artwork
- Timely Submission of Nonclinical Overview and Nonclinical Summaries
- Timely and Accurate Submission of CEP Applications
- Timely and Compliant Submission of DMF Application with 100% Accuracy
- Toxicological Evaluation and Preparation of MSDS/SDS
- Toxicological Safety Assessment for Cosmetic Ingredients
- Transfer of Ownership of ANDA for 31 Products in a single day
- Transfer of Ownership of ANDA for 6 Products
- Two Step Review Process for Accelerating DMF Submissions
- UDI Submission to the GUDID Database for Moderate Risk Devices
- Update the CTD Dossier and Successful Submission of ‘Type C’ Amendment
- Updating Clinical Evaluation Report (CER) for EU MDR Compliance
- What Is A Scientific Validity Report (SVR)?
- ZACTD Preparation with ‘Type A’ Amendments
- ZACTD Preparation with ‘Type C’ Amendments
- Zero Defect Largest NDA Submission Delivered in Reduced Timeline from 2 Months to 5 Days
- Zero Deficiency Submissions to the USFDA with Quick TAT
- Zero Deficiency and Compliant Baseline Submissions to the USFDA
- Zero Deficiency and Compliant IND Submissions to the USFDA
- Zero Error DMF Submission to the USFDA
- Zero-Error IND Submissions to the USFDA
- Zero-error Europe MAA Submission in eCTD Format
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