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

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

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

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