Core Services
GMP expertise, across the compliance lifecycle
Practical, regulator-aligned services that strengthen quality systems and ensure inspection readiness.
GMP Consulting & Advisory
Strategic guidance to design, scale, and optimize GMP-compliant operations aligned with global regulations. Our consultants work closely with your team to develop customized solutions that fit your specific operational context and business objectives.
- • Facility design and layout optimization
- • Process development and scale-up support
- • Regulatory strategy and planning
GMP Auditing & Compliance Assessments
Comprehensive audits and assessments to identify gaps and ensure regulatory compliance across all operations. We provide detailed findings with prioritized recommendations for remediation.
- • Pre-inspection audits
- • Gap analysis and risk assessment
- • Supplier and vendor audits
Regulatory Inspection Readiness & Remediation
Prepare for regulatory inspections and implement effective remediation strategies for identified issues. We help you navigate the inspection process with confidence.
- • Inspection preparation workshops
- • Mock inspections and simulations
- • Remediation planning and execution
Quality Management Systems (QMS)
Design and implement robust quality management systems that meet international standards and best practices. We help you build systems that are both compliant and efficient.
- • QMS design and documentation
- • SOP development and optimization
- • Change control and CAPA systems
Computer System Validation (CSV)
We provide end-to-end Computer System Validation services for pharmaceutical companies, ensuring your systems comply with GxP, FDA, and EMA requirements. Our expertise helps you maintain regulatory compliance, data integrity, and operational efficiency.
- • Validation Planning: CSV strategy, risk assessment, and validation master plan (VMP)
- • Requirement Specifications: User Requirement Specification (URS) creation and review
- • System Testing & Documentation: Functional testing (IQ/OQ/PQ), validation reports, and SOP support
- • Audit & Compliance Support: Gap analysis, remediation, and regulatory submission support
- • Periodic Review & Revalidation: Ensuring ongoing compliance for critical systems
