Our Services

GxP Compliance Audits – Ensuring adherence to GMP, GLP, and GCP regulations.
Internal Audits – Evaluating internal processes to identify gaps and ensure regulatory readiness.
Supplier & Vendor Audits – Assessing third-party compliance, quality systems, and risk mitigation strategies.
Regulatory Inspection Readiness – Preparing organizations for FDA, EMA, MHRA, and other regulatory body inspections.
Quality System Audits – Reviewing SOPs, documentation, CAPAs, deviations, and change controls for compliance and efficiency.
Data Integrity Audits – Verifying ALCOA+ principles to ensure data accuracy, reliability, and security.
Risk-Based Auditing – Identifying and prioritizing high-risk areas to strengthen quality and compliance.

Comprehensive Commissioning & Qualification of Equipment & Systems (DQ/IQ/OQ/PQ) – Ensuring proper design, installation, functionality, and performance of systems through Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that Facilities, Utilities, Systems, and Equipment (FUSE) are fit for their intended use.
Computer System Validation (CSV) – Ensuring software and computerized systems comply with FDA 21 CFR Part 11 and other regulatory requirements.
Risk-Based Approach to Validation – Applying risk management principles to optimize validation efforts and compliance.

Quality Assurance Validation – Overseeing CQV activities, ensuring validation protocols, reports, and engineering work comply with regulatory requirements and industry best practices.
Quality Assurance for Batch Disposition – Supporting batch release by reviewing batch records (MBRs), deviation reports, and quality documentation to ensure product safety and compliance before disposition.
Quality Assurance Operations – Providing real-time QA support to manufacturing operations, ensuring adherence to GMP, SOPs, and regulatory guidelines throughout production processes.
Quality Management Systems (QMS) – Managing and reviewing deviations, CAPAs, change controls, and other QMS records to maintain compliance, continuous improvement, and operational excellence.

Project Planning & Execution – Managing project timelines, resources, and deliverables to ensure successful execution from initiation to completion.
Cross-Functional Team Coordination – Facilitating collaboration between engineering, validation, quality, and manufacturing teams to meet project goals.
Technology Transfer & Scale-Up – Overseeing the transition from development to commercial manufacturing, ensuring smooth scale-up and process optimization.
Process Improvement & Optimization – Identifying and implementing solutions to enhance operational efficiency and product quality.
Risk Management & Mitigation – Assessing potential risks and developing strategies to minimize impact on project timelines and compliance.