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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
- ANDA and PADER Submissions with Zero Deficiency
- Accelerated ASMF submissions in the EU within two weeks
- Accelerating Ahead Of Competition Delivering Faster Time to Approval
- CCDS Process Establishment to Audit Preparedness and Support
- Comprehensive Regulatory Artwork Support with 99.99% Quality Deliverables
- 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
- Device Classification, Regulatory Approach Identification and Registration Services in Mexico
- EMA Compliant Health Based Risk Assessment (PDE)
- 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 TMF Gap Analysis, eTMF deployment and CAPA resolution
- 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 Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions
- End-to-end Toxicology Risk Assessment services for Perfumes in European Economic Area
- Error-free Major Variation Submissions in eCTD format to Australia
- 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
- Medical Device Classification Support in India (As Per CDSCO)
- Product Registration and Variation Submissions to 12 African Countries
- QMS Remediation and SOP Rationalization for On-Time Audit Readiness
- Quick SOP standardization and Rationalization to Streamline the Processes
- RI Report on Digital Clinical Trial Data Capture System in the US and EU
- Regulatory Intelligence on PPO Policies in India
- Saved Over 60% in Cost of Compliance and 360 Man Hour Effort
- Saved Over 60% in Cost of Compliance and 360 Man Hour Effort
- Successful 50+ SPL Submissions In 20 Days
- Successful 50+ SPL Submissions In 20 Days
- Successful ANDA Filing with zero deficiency
- Successful BLA Submissions with Zero Deficiencies for US Region
- Successful Baseline Paper to eCTD submissions to GCC Oman
- Successful Completion of 4 High Quality CSR Publishing in Short TAT
- Successful DIN Submissions in eCTD format to Health Canada
- Successful DMF Filings in the USA and Canada
- Successful DMF submissions within one week that yielded 70% cost benefits
- Successful Execution of More Than 250 Clinical Trials across Locations
- Successful GMP Audit Services Avoiding Potential Non-conformances
- Successful Global Regulatory Assessment and Roadmap Preparation
- Successful IND Submission in 4 Weeks saving 70% on Cost of Compliance
- Successful Medicinal Product Registration in Indonesia
- Successful NDA - Medical Device Submission in Reduced Delivery Time frame (from 50 days to 16 Days)
- 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 SPL Submission in 2 Weeks, Increasing 50% in Cost of Compliance Benefits
- Successful Type III DMF Compilation and eCTD Submission to USFDA
- Successful eTMF System Build and Centralization
- 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
- 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 Provision of Regulatory Staffing Services for Regulatory Affairs, Operations, XEVMPD, Artwork
- Zero Defect Largest NDA Submission Delivered in Reduced Timeline from 2 Months to 5 Days
- Zero-error Europe MAA Submission in eCTD Format
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