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- 100% Accurate MAA and Baseline Submission in Middle East and Switzerland
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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
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- ANDA and PADER Submissions with Zero Deficiency
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- On-time Delivery of 125 PDE Reports to the MHRA
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- Performed Gap Analysis and Successful Submission of ANDA to the USFDA
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- Preparation And Submission of DMF Amendments in eCTD Format to FDA, TPD
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- Product Registration and Variation Submissions to 12 African Countries
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- RI Report on Digital Clinical Trial Data Capture System in the US and EU
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- 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
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- 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 NMC Meeting with COFEPRIS
- Successful Conversion of 17 Existing DMFs into eCTD
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- Successful DIN Submissions in eCTD format to Health Canada
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- 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
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- Successful Execution of More Than 250 Clinical Trials across Locations
- Successful Filing of DMF and Amendments in the USA
- Successful GMP Audit Services Avoiding Potential Non-conformances
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- 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
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- Successful Identification of Medical Device Category in the EU Region
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- Successful MAA Filings with Zero Deficiency
- Successful Management of Product Registrations with Freyr PRISM
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- Successful NDA - Medical Device Submission in Reduced Delivery Time frame (from 50 days to 16 Days)
- Successful Preparation and Submission of 15+ IBs
- 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
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- 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
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- Technical Review of BMR in accordance with USFDA
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- Technical Support for Submission of 2 DMFs in eCTD
- 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
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- Transfer Of Ownership of ANDA for 31 Products in a single day
- Transfer Of Ownership of ANDA for 6 Products
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