GxP Audit – Quality, Compliance, GxP Excellence

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MEDIATURE GxP

Building Quality. Ensuring Compliance.

Professional GxP, regulatory and quality management solutions for pharmaceutical and healthcare organizations.

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OUR EXPERTISE

GxP & Other Compliance Solutions

Comprehensive quality, regulatory and compliance solutions for regulated pharmaceutical organizations.

01 Commissioning, Qualification & Validation

02 CSV & Digitalization

03 EHS, Energy & Sustainability

04 Energy Management Solutions

05 Engineering, Facility, EHS & Energy Solutions

06 GxP Audits & Assessments Independent, risk-based audits and compliance assessments to strengthen quality systems, identify regulatory gaps, and support inspection readiness.

07 Pharmaceutical Engineering & Facility Solutions

08 Pharmacovigilance Services

09 Product Development & Technology Transfer

10 Quality & Compliance Practical quality-system and compliance support to strengthen control, improve consistency, and maintain inspection readiness.

11 Regulatory Strategy & Intelligence Strategic and operational regulatory support across product development, submissions, approvals, and lifecycle management.

12 Training & Capability Development

01 · COMMISSIONING, QUALIFICATION & VALIDATION

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Commissioning & Qualification Commissioning & Qualification Facility Qualification Facility Qualification Utility Qualification Utility Qualification Equipment Qualification Equipment Qualification HVAC & Cleanroom Qualification HVAC & Cleanroom Qualification Process Validation Process Validation Cleaning Validation Cleaning Validation Validation Master Plan Validation Master Plan Qualification Protocols & Reports Qualification Protocols & Reports Periodic Review & Requalification Periodic Review & Requalification Validation Lifecycle Support Validation Lifecycle Support

02 · CSV & DIGITALIZATION

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Computer System Validation Computer System Validation Data Integrity Assessment Data Integrity 21 CFR Part 11 Compliance 21 CFR Part 11 Digital QMS Digital QMS Computer Software Assurance Computer Software Assurance GAMP 5 Compliance GAMP 5 Compliance EU Annex 11 Compliance EU Annex 11 Compliance Electronic Document Management Systems Electronic Document Management Systems Data Migration Validation Data Migration Validation Interface & API Validation Interface & API Validation Cloud System Assessment Cloud System Assessment Vendor & System Qualification Vendor & System Qualification Digital Transformation Support Digital Transformation Support

03 · EHS, ENERGY & SUSTAINABILITY

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Energy Energy EHS EHS Sustainability Sustainability

04 · ENERGY MANAGEMENT SOLUTIONS

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Energy Performance Benchmarking Energy Performance Benchmarking

05 · ENGINEERING, FACILITY, EHS & ENERGY SOLUTIONS

View Engineering, Facility, EHS & Energy Solutions →

Facility Design Review & Engineering Consultancy GMP Engineering Compliance Audits GMP Engineering Compliance Audits Utility System Assessment & Optimization Utility System Assessment & Optimization HVAC System Evaluation & Qualification HVAC System Evaluation & Qualification Equipment Qualification & Validation Equipment Qualification & Validation Maintenance Excellence Programs Maintenance Excellence Programs Engineering Project Management Engineering Project Management Engineering Project Management Engineering Project Management Turnkey Engineering Compliance Solutions Turnkey Engineering Compliance Solutions Facility Layout Review Facility Layout Review Conceptual, Basic & Detailed Engineering Conceptual, Basic & Detailed Engineering

06 · GXP AUDITS & ASSESSMENTS

Independent, risk-based audits and compliance assessments to strengthen quality systems, identify regulatory gaps, and support inspection readiness.

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Computerized System / CSV Audits Independent audits to assess computerized-system compliance, strengthen data governance, and protect the... GVP / Pharmacovigilance Audits Independent pharmacovigilance audits to assess system compliance, strengthen safety processes, and support... GMP Audits Independent GMP audits to identify compliance gaps, strengthen quality systems, and support... GDP Audits Independent GDP audits to strengthen storage, transportation, traceability, and distribution controls across... Vendor and Supplier Audits Independent supplier and vendor audits to strengthen qualification, oversight, and compliance across... GLP Audits Independent GLP audits to strengthen laboratory quality systems, protect data integrity, and... GCP Audits Independent GCP audits to protect participant rights, strengthen clinical quality systems, and... Quality System Audits Independent quality-system audits to identify compliance gaps, strengthen QMS effectiveness, and support... Engineering Compliance Audits Independent audits to assess facility design, engineering systems, utilities, maintenance, qualification status,... Factory Acceptance Testing (FAT) Audits / Witnessing Independent FAT audit and witnessing support to verify equipment compliance, functionality, documentation,... Due Diligence / Gap Assessments Independent assessments to identify compliance risks, evaluate operational readiness, and support informed...

07 · PHARMACEUTICAL ENGINEERING & FACILITY SOLUTIONS

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Equipment Selection & Technical Evaluation Equipment Qualification HVAC & Cleanroom Qualification HVAC & Cleanroom Qualification Conceptual, Basic & Detailed Engineering Process & Cleaning Validation Engineering Compliance Assessments Engineering Compliance Assessments New Facility Planning & Design New Facility Planning & Design GMP Engineering Compliance GMP Engineering Compliance Utility Systems Design & Assessment GMP Engineering Compliance Engineering Project Management Engineering Project Management Procurement Support Procurement Support Construction & Installation Support Construction & Installation Support High-Potency & Containment Facility Design High-Potency & Containment Facility Design Turnkey Engineering Support Turnkey Engineering Support Green Building & Sustainable Facility Design Green Building & Sustainable Facility Design

08 · PHARMACOVIGILANCE SERVICES

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ICSR Case Management ICSR Case Management Safety Database Management Safety Database Management Signal Management Signal Management Literature Monitoring Literature Monitoring Aggregate Reporting Aggregate Reporting Risk Management Risk Management PV SOP Development PV Regulatory & Quality Compliance PV Training PV Training & Support SDEA/PVA Management SDEA/PVA Management PSMF Support PSMF Support PV Quality & Compliance PV Quality & Compliance

09 · PRODUCT DEVELOPMENT & TECHNOLOGY TRANSFER

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Product Development Support Product Development Support Process Development Process Development Analytical Development Support Analytical Development Technology Transfer Technology Transfer Scale-Up Support Scale-Up & Process Optimization Process Optimization Process Optimization Technical Troubleshooting Technical Troubleshooting Development Documentation Development Documentation Formulation Development Support Formulation Development Support

10 · QUALITY & COMPLIANCE

Practical quality-system and compliance support to strengthen control, improve consistency, and maintain inspection readiness.

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Change Control Structured change-control support to assess impact, manage risk, and maintain the validated... Quality Management System Development Structured QMS development and improvement support to strengthen governance, compliance, consistency, and... CAPA Management Structured CAPA support to address root causes, prevent recurrence, and strengthen quality-system... Deviation & OOS/OOT Management Structured investigation and quality-event management support to identify root causes, reduce recurrence,... Data Integrity & Good Documentation Practices Practical data-integrity and documentation support to strengthen record reliability, traceability, accountability, and... Quality Risk Management (QRM) Structured, science-based risk management support to identify, evaluate, control, communicate, and review... Gap Assessment & Remediation Structured compliance gap assessments and practical remediation support to strengthen systems, reduce... SOP Development & Review Practical SOP development and lifecycle support to standardize processes, strengthen compliance, and... Contamination Control Strategy Structured contamination-control support to identify contamination risks, strengthen preventive controls, and maintain... Inspection Readiness Structured inspection-readiness support to strengthen systems, prepare teams, and reduce regulatory risk... Quality Metrics & Management Review Structured quality-performance monitoring and management-review support to strengthen oversight, identify trends, and...

11 · REGULATORY STRATEGY & INTELLIGENCE

Strategic and operational regulatory support across product development, submissions, approvals, and lifecycle management.

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Medical & Regulatory Writing Clear, accurate, and compliant scientific writing support for regulatory, clinical, safety, and... Regulatory Strategy and Intelligence Practical regulatory planning and intelligence support to help organizations understand requirements, select... Dossier Compilation & Review Structured dossier preparation and technical review support to improve completeness, consistency, and... CTD/eCTD Support Structured CTD and eCTD support to improve dossier organization, technical consistency, and... Regulatory Submission Support Coordinated regulatory submission support to improve completeness, consistency, and readiness across application... Regulatory Query Response Support Structured support for assessing, coordinating, drafting, and tracking responses to regulatory authority... Product Registration Support Structured product registration support to help organizations prepare compliant documentation, coordinate submissions,... Variations & Renewals Structured post-approval regulatory support to manage product changes, maintain registrations, and ensure... Regulatory Lifecycle Management Ongoing regulatory support to maintain product approvals, manage post-approval obligations, and keep... Artwork & Labelling Review Regulatory and quality-focused review of product labelling and artwork to improve accuracy,... Regulatory Gap Assessment Structured regulatory assessments to identify documentation, compliance, and lifecycle gaps before they...

12 · TRAINING & CAPABILITY DEVELOPMENT

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GMP & GxP Training GxP Training Regulatory & Guidelines Training Regulatory & Guidelines Training Data Integrity Training Refresher Training Soft Skills & Workforce Enhancement Soft Skills & Workforce Enhancement Train-the-Trainer Programs Train-the-Trainer Programs CSV & GAMP Training Audit Readiness Training Quality & Compliance Training POSH Training Industrial & Graduate Training Industrial Training EHS & Safety Training EHS & Safety Training Audit Readiness & Auditor Development Audit Readiness & Auditor Development Qualification & Validation Training Qualification & Validation Training Pharmacovigilance Training Pharmacovigilance Training

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Commissioning & Qualification Facility Qualification Utility Qualification Equipment Qualification HVAC & Cleanroom Qualification Process Validation Cleaning Validation Validation Master Plan Qualification Protocols & Reports Periodic Review & Requalification Validation Lifecycle Support

Computer System Validation Data Integrity Assessment 21 CFR Part 11 Compliance Digital QMS Computer Software Assurance GAMP 5 Compliance EU Annex 11 Compliance Electronic Document Management Systems Data Migration Validation Interface & API Validation Cloud System Assessment Vendor & System Qualification Digital Transformation Support

View All Energy Comprehensive Energy Audits Utility Consumption Assessment HVAC Energy Optimization Compressed Air System Efficiency Audits Boiler & Steam System Optimization Chiller & Cooling System Performance Assessment Electrical System Energy Audits Renewable Energy Feasibility Studies

View All EHS EHS Gap Assessment Occupational Health & Safety Hazard Identification & Risk Assessment (HIRA) Process Safety Management (PSM) Fire & Life Safety Audits Emergency Response Planning Environmental Compliance Audits Waste Management

View All Sustainability Waste Reduction Resource Optimization Green Building Support Sustainability Programs

Energy Performance Benchmarking

Facility Design Review & Engineering Consultancy GMP Engineering Compliance Audits Utility System Assessment & Optimization HVAC System Evaluation & Qualification Equipment Qualification & Validation Maintenance Excellence Programs Engineering Project Management Engineering Project Management Turnkey Engineering Compliance Solutions Facility Layout Review Conceptual, Basic & Detailed Engineering

Computerized System / CSV Audits GVP / Pharmacovigilance Audits GMP Audits GDP Audits Vendor and Supplier Audits GLP Audits GCP Audits Quality System Audits Engineering Compliance Audits Factory Acceptance Testing (FAT) Audits / Witnessing Due Diligence / Gap Assessments

Equipment Selection & Technical Evaluation HVAC & Cleanroom Qualification Conceptual, Basic & Detailed Engineering Engineering Compliance Assessments New Facility Planning & Design GMP Engineering Compliance Utility Systems Design & Assessment Engineering Project Management Procurement Support Construction & Installation Support High-Potency & Containment Facility Design Turnkey Engineering Support Green Building & Sustainable Facility Design

View All ICSR Case Management Case Processing Quality & Medical Review Regulatory Reporting

View All Safety Database Management Data Entry & Validation E2B (R3) XML Generation

View All Signal Management Signal Detection & Evaluation

View All Literature Monitoring Weekly Literature Screening

View All Aggregate Reporting PSUR/PBRER Support

View All Risk Management RMP & REMS Support

View All PV SOP Development SDEA/PVA Management SOP Development PSMF Support

View All PV Training SOP Training

SDEA/PVA Management PSMF Support PV Quality & Compliance

Product Development Support Process Development Analytical Development Support Technology Transfer Scale-Up Support Process Optimization Technical Troubleshooting Development Documentation Formulation Development Support

Change Control Quality Management System Development CAPA Management Deviation & OOS/OOT Management Data Integrity & Good Documentation Practices Quality Risk Management (QRM) Gap Assessment & Remediation SOP Development & Review Contamination Control Strategy Inspection Readiness Quality Metrics & Management Review

Medical & Regulatory Writing Regulatory Strategy and Intelligence Dossier Compilation & Review CTD/eCTD Support Regulatory Submission Support Regulatory Query Response Support Product Registration Support Variations & Renewals Regulatory Lifecycle Management Artwork & Labelling Review Regulatory Gap Assessment

View All GMP & GxP Training GMP, GDP & GLP Data Integrity & ALCOA++ Principles GxP Fundamentals & Best Practices

View All Regulatory & Guidelines Training Schedule M Updates US FDA Requirements MHRA Requirements GAMP 5 & Computerized Systems Regulatory Updates & Compliance Changes

View All Data Integrity Training Fundamentals Refresher Practical, Interactive & Case-Based Learning Latest Regulatory & GMP Changes

View All Soft Skills & Workforce Enhancement Productivity Enhancement Personality Development Communication & Team Effectiveness Workforce Enhancement

View All Train-the-Trainer Programs Trainer Development & Assessment Effective Training Techniques

View All CSV & GAMP Training GMP Audit Skills Auditor Development Audit Preparation & Execution Observation Writing & Reporting

View All Quality & Compliance Training Workplace Awareness & Compliance Prevention of Sexual Harassment

View All Industrial & Graduate Training Training Programs for College Freshers & Graduates Practical GxP Training Pharma Industry Orientation

EHS & Safety Training Audit Readiness & Auditor Development Qualification & Validation Training Pharmacovigilance Training

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Mediature GxP Solutions Private Limited provides professional GxP, GMP, quality, regulatory, pharmacovigilance and pharmaceutical consulting solutions to support quality, compliance and operational excellence.

GXP AUDIT – QUALITY, COMPLIANCE, GXP EXCELLENCE

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