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      • 100% Accurate MAA and Baseline Submission in Middle East and Switzerland
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      • 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
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      • Regulatory Services For Listing Newly Regulated Medical Devices in India
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      • Regulatory Support For Successful PLLR Conversion
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      • Regulatory Support for Food Supplements Classification in Canada
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      • Regulatory Support for Submission of Complex CSRs
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      • 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
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      • 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
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      • 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
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      • 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
      • 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
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      • 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
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      • Timely and Compliant Submission of DMF Application with 100% Accuracy
      • 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
      • Update the CTD Dossier and Successful Submission of ‘Type C’ Amendment
      • What Is A Scientific Validity Report (SVR)?
      • ZACTD Preparation with ‘Type A’ Amendments
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      • 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
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      The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

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      Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

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      Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

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  3. Case Studies
  • US FDA
    Regulatory Labeling

    Comprehensive Gap Analysis of the Labeling Based on 21CFR801

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  • Global
    Compliance, Audit and Validation, Regulatory Labeling, Regulatory Software & Services

    End-to-End Implementation of A Validated Document Management System (DMS) for Labeling on OpenText™

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    Regulatory Labeling

    Successful Regulatory Support for Regional Labeling Operations and Process Improvement

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    Successful Global Regulatory Assessment and Roadmap Preparation

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  • US FDA
    Regulatory Labeling

    Successful SPL Submission Within 2 Weeks With 50% Increase In Cost Benefits

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