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NPRARegulatory Labeling
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NPRARegulatory Labeling
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MHRARegulatory Labeling
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European Medicines Agency, US FDARegulatory Labeling
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GlobalCompliance, Audit and Validation, Regulatory Labeling, Regulatory Software & Services
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- 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
- 25 PLLR Conversions for Generics
- 345, 177 and 198 Submissions for ROW, EU and US Respectively Within 3 Months With 100 % Acceptance
- 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
- ANDA Re-submission Post RTR
- ANDA Submission with Zero Deficiencies
- ANDA and PADER Submissions with Zero Deficiency
- ASMF Cover Letter Preparation For the EU Countries
- 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
- Artwork Creation for New and Compliant Brand Designs
- Artwork Quality Check Within Reduced TAT, from 5 Days to 1 Day
- 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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