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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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- 24x7 Support with Global Delivery Model to Meet Stringent Deadlines
- 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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- Artwork Centralization & migration of 11,000 legacy artworks
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- Artwork Creation and Technical Review For Successful Indian Market Entry
- CCDS Process Establishment to Audit Preparedness and Support
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- Compilation and Preparation of CDS for 80 Products
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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
- 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
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- 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
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- Quick SOP standardization and Rationalization to Streamline the Processes
- Quick TAT with 100% Accurate ANDA Filings
- RI Report on Digital Clinical Trial Data Capture System in the US and EU
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- Regulatory Framework Report on Approval of Anti-viral Antisera Products in the USA and EU
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- 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
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- Successful Authoring of 45 Protocols and Protocol Amendments
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- Successful Classification & Registration of Medical Device in Vietnam
- Successful Classification & Registration of Medical Device in the US and EU
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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 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 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
- Successful IND and NDA Submission to the USFDA
- Successful Identification of Medical Device Category in the EU Region
- 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 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 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
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- Timely Preparation and Evaluation of 250 PDE
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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
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- Update the CTD Dossier and Successful Submission of ‘Type C’ Amendment
- ZACTD Preparation with ‘Type A’ Amendments
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- Zero Deficiency Submissions to the USFDA with Quick TAT
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