Our Services
Regulatory Licensing Support
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CDSCO Manufacturing License (MD-5 / MD-9) as per IMDR 2017
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CDSCO Import License (MD-15)
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CDSCO Loan License (MD-6 / MD-10)
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Free Sale Certificate (FSC)
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Market Standing Certificate
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CE Marking (EU MDR 2017/745 & EU IVDR 2017/746)
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USFDA Approval, 510 K
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WHO-GMP / CDSCO compliance for Pharma products
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BIS Approval of Products
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ZED Certification
Management System Training and Implementation
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ISO 13485:2016 & ISO 9001:2015
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Environmental Management System (EMS)
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Health & Safety Management System
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Food Safety Management System
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Social Accountability Management System
Turnkey Project Process Flow – Medical Devices
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Project Initiation & Feasibility
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Facility Planning & Layout Design
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Regulatory Strategy & Approvals
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Documentation Development
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Procurement & Installation
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Validation & Qualification
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QMS Implementation
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Regulatory Submission
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Audit & Inspection Support
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Commercial Launch
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Post-Market Compliance
Process Flow – Retainership Model
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Onboarding & Requirement Assessment
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Gap Analysis & Compliance Roadmap
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QMS Maintenance & Implementation Support
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Regulatory Compliance Management
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Training & Awareness Programs
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Internal Audits & Mock Inspections
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Management Review & Reporting
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Continuous Improvement & Updates
Business Excellence & Quality Improvement
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Quality Management System (QMS) Strengthening
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Process Improvement & Optimization
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Lean & Six Sigma Implementation
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Internal Audits & Compliance Excellence
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CAPA & Risk Management
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Training & Capability Building
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Performance Metrics & KPI Management
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Supplier Quality Management
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Digital Quality & Documentation Systems
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Continuous Improvement Programs