Services
We provide comprehensive advisory and managed support services for pharmaceutical manufacturers and healthcare organizations.
GMP Compliance & Audits
Expert guidance on regulatory standards and audit readiness for pharmaceutical manufacturing environments.
• GMP gap assessments and compliance reviews
• Internal, supplier, CMO and due-diligence audits
• Inspection readiness and mock inspections
• Audit-response and CAPA remediation support
• Data-integrity and documentation-practice assessments
• Aseptic manufacturing and contamination-control reviews
Operational Managed Support
Strategic oversight and managed support services to ensure seamless operations and regulatory compliance.
• Interim and fractional Quality leadership
• Day-to-day Pharmaceutical Quality System oversight
• Deviation, investigation, CAPA and complaint management
• GMP documentation preparation, review and approval support
• Quality risk and impact assessments
• Remediation and backlog-reduction programmes
• Support during start-up, scale-up, technology transfer and site expansion
Regulatory Strategy
Expert advisory on navigating complex regulatory landscapes and ensuring global market access.
• Regulatory-impact assessments for changes and deviations
• GMP and dossier-compliance reviews
• Support for commitments, deficiency letters and regulatory responses
• Assessment of registered versus actual manufacturing and testing practices
• Regulatory strategy for technology transfers and manufacturing changes
• Review of specifications, analytical methods and product documentation
• Risk-based strategies for resolving compliance gaps
Quality Management Systems
Implementation and optimization of quality management systems to drive operational excellence.
• Design and implementation of Pharmaceutical Quality Systems
• Quality-system transformation, remediation and upgrades
• Escalation paths and management oversight
• GMP documentation preparation, review and optimisation
• Quality manuals, SOPs, work instructions, forms and templates
• Deviation, CAPA, change-control, complaint and recall systems
• OOS/OOT, Product Quality Review and Quality Management-Review processes
• Quality metrics, governance and continuous improvement
Training & Capability Building
Comprehensive training programs designed to build internal capacity and ensure regulatory compliance.
• GMP and Good Documentation Practice training
• Deviation investigation and root-cause-analysis workshops
• CAPA, change-control and quality-risk-management training
• Data-integrity and inspection-readiness programmes
• Aseptic manufacturing and contamination-control training
• Role-specific training for Quality, Production, QC and management teams
• Training-system design and effectiveness evaluation
Quality Control & Lab Compliance
• SOPs, laboratory procedures, roles & responsibilities
• ALCOA++ controls, audit trails, records and review practices
• Specifications & methods- Lifecycle governance and technical review
• Stability & sample management- Programs, storage, trending and end-to-end traceability
• Quality control systems and Lab governance
• OOS/OOT investigation support
GMP-focused support for QC operations, laboratory compliance and inspection readiness
CMO & External Supply Quality Management
We provide specialized advisory services designed to ensure pharmaceutical and healthcare companies meet the highest global standards of quality and compliance.
• CMO/CDMO qualification, onboarding and ongoing oversight
• Quality and Technical Agreement preparation and review
• Batch, deviation, investigation, CAPA and complaint oversight
• Change-control and regulatory-impact assessments
• Supplier performance monitoring and quality governance
• Product-release readiness and documentation review
• Technology-transfer and validation oversight
• Coordination between MAHs, manufacturing sites, laboratories and suppliers