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- 100% Accurate MAA and Baseline Submission in Middle East and Switzerland
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- 150+ MA’s successfully Submitted within 1 Month Increasing the Cost Benefits By 50%
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- 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
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- 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, review, and submission of amendments Update for 4 products
- Complete Review and Compilation of Module 1
- Completion of GMP Audits for Two Sites
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- Compliant IND Submissions to the USFDA with Quick TAT
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- 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
- 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 Artwork Process Transition with Zero Recalls
- End-to-End Cosmetic Product Compliance Check in Japan
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- 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 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
- GCP Audit Services for EU submission in quick TAT
- GMP Audit Services for Establishing Management Systems Post-Acquisition
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- GMP Audit as per the MHRA Guidelines
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- 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
- High Quality GMP Audit in Quick TAT
- Initial Registration of Medical Device and Submission of MDMA
- Initial Registration of the Product and Submission to the SFDA
- 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
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- On-time Submission of 10 IBs for Multiple Regions
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- 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
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- QMS Remediation Services Along with End-to-End Gap Analysis
- QMS Remediation and Audit Finding Closures in Saudi Arabia
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- Quick SOP standardization and Rationalization to Streamline the Processes
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- RI Report on Digital Clinical Trial Data Capture System in the US and EU
- 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 Framework Report on Approval of Anti-viral Antisera Products in the USA and EU
- Regulatory Intelligence on PPO Policies 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
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- Regulatory Support for Food Supplements Classification in Canada
- Regulatory Support for Submission of Complex CSRs
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- 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 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 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
- 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
- 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
- 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
- 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
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