Our Consulting and QMS Service Offerings
Our services ensure regulatory compliance, robust quality systems, and operational efficiency,
supporting clients from conceptual design through commercial production.
Documentation and Quality Management System (QMS) Implementation
- Complete QMS implementation solutions in line with ICH, EU GMP, WHO, and USFDA requirements.
- Designing and development of key quality documents, including:
- Quality Manual
- Validation Master Plan (VMP)
- Site Master File (SMF)
- Standard Operating Procedures (SOPs)
- Standard Test Procedures (STPs)
- Quality Policies and Templates
- Validation protocols and technical reports
- Comparability protocols
- Technology Transfer Documents
- Focused on regulatory compliance, process efficiency, and continuous improvement.
Gap Assessment & Compliance Readiness
- Comprehensive gap assessments of facilities, systems, and processes against global GMP and regulatory standards.
- Identification of deficiencies, risks, and areas of improvement with actionable recommendations.
- Ensuring audit readiness for global regulatory inspections.
Risk Assessments & Contamination Control Strategy (CCS)
- Conducting comprehensive risk assessments for processes, equipment, facilities, utilities and so on.
- Development of Contamination Control Strategies to ensure product safety and GMP compliance.
- Implementation of risk-based approaches (ICH Q9) for proactive quality improvement.