QMS Support — Practical. Compliant. Sustainable.
End-to-end Quality Management System (QMS) support for pharmaceutical organizations: from assessment and system design to implementation, validation, and continuous improvement.
1. SOP Writing & Documentation Support
We develop and streamline Standard Operating Procedures (SOPs) that are clear, compliant, and easy to execute. Our approach ensures your documentation aligns with current GMP, ISO, and regulatory expectations.
- Creation and review of SOPs, policies, and work instructions
- Standardized templates and controlled documentation systems
- Cross-functional document harmonization and version management
2. Validation Master Plan (VMP) Development
We prepare comprehensive Validation Master Plans that define the validation strategy for facilities, utilities, and computerized systems — fully aligned with regulatory guidance.
- Facility, utility, and process validation planning
- Computerized System Validation (CSV) framework
- Periodic review and lifecycle management support
4. Specialized Training & Competency Development
We deliver customized GMP and QMS training modules for management and shop-floor personnel, ensuring consistent understanding and application of quality principles.
- GMP, GDP, Data Integrity, and Quality Culture programs
- Role-based training for QA, QC, and Production teams
- Effectiveness evaluation and retraining plans
5. Outsourcing of Quality & Compliance Roles
We provide qualified professionals and embedded consultants to support your operational and regulatory needs — short-term or long-term.
- Qualification validation experts and Computer System Validation experts (CSV) support
- QA and QC specialists (onsite or remote)
- Audit and inspection readiness consultants
6. Support in Regulatory Inspections
From pre-inspection preparation to on-site support and post-inspection CAPA closure, we help clients successfully face authorities such as FDA, EMA,MHRA, ANVISA, and COFEPRIS.
- Mock inspections and documentation review
- Effectively implementation of the observation during the gap audit
- support during a regulatory inspection
- Training for inspection handling and communication
- post-inspection remediation and CAPA management
