SERVICES
We serve as your external consulting partner for compliance readiness and remediation endeavors.
We offer top-tier consultants, quality experts, and advisors, all deeply committed to addressing your quality-centric challenges.
Our regulatory compliance services include on-site and virtual third-party and mock audits, compliance assessments, remediation plans development, site inspection readiness and enhancement plans, third-party oversight, data integrity and DIRA, quality culture and sustainability of compliance, quality communications plan design, investigations backlog resolution, CAPA effectiveness, root cause analysis, SOP simplification, records management and document controls, storyboard creation and improvement, and quality systems enhancement.
Start Up of Facilities
C&Q: Facilities, Equipment, Utilities
Process Validation: Stages 1 - 3
Continuous Process Verification (CPV)
Cleaning Validation
Computer Systems Validation
Capacity Expansion: C&Q & Validation
Systems Development Lifecycle Management (SDLC):
Seven Stages: Requirements & Analysis, Project Planning, Design, Coding & Implementation, Testing ,Deployment, Maintenance.
URS, DS,
FAT, SAT
Traceability Metric (TM)
Validation Master Plans
Validation Protocols
Validation Protocols Execution
Validation Reports
We offer comprehensive project management services, including PMO services, project plans and management tools, progress metrics, reporting and dashboards, risk evaluation and mitigation, milestones and resource loading, change management processes, and project budgeting.
Risk Management Tools
QRM Plans
DIRA’s
Risk Assessments
Risk Mitigation
Risk Control
Risk Communication
Risk Review
Facilitation Methods:
Failure Mode Effects Analysis (FMEA)
Failure Mode, Effects and Criticality Analysis (FMECA
Fault Tree Analysis (FTA)
Hazard Analysis and Critical Control Points (HACCP)
Hazard Operability Analysis (HAZOP)
Preliminary Hazard Analysis (PHA)
Risk Ranking and Filtering
Compliance with ALCOA and ALCOA+ elements.
DIRA (Data Integrity Risk Assessments)
Data Integrity Audits: Comprehensive audits of data systems, processes, and practices to identify vulnerabilities and non-compliance issues.
Gap Analysis and Risk Assessment: Assessing current data management practices to identify gaps and potential risks to data integrity.
Periodic Reviews and Reconciliation: Conducting periodic reviews of data to ensure consistency, accuracy, and compliance.
Continuous Improvement Initiatives: Establishing programs to continuously improve data integrity practices and adapt to evolving regulations.
Regulatory Compliance Assistance: Providing guidance and support to meet regulatory requirements related to data integrity.
We provide comprehensive support for technology transfer, including startup product transfer support, tech transfer strategy, process development, characterization, engineering studies, stability runs, registration runs, product and method transfer support, process performance qualification, process validation, regulatory agency changes filing and registration, and scale-up and post-approval changes (SUPAC).
Data Engineering & Visualization
Descriptive, diagnostic, predictive, and prescriptive analytics
Design, development, deployment, and maintenance of strategic, operational and analytic dashboards
Root cause analysis, confounding variables, model cause-effect relationships
Data analytics, data mining, statistical analysis: Historical and actual data
We offer a range of services under Knowledge & Talent Management, including training and mentoring, skill enhancement, coaching, and contingent talent sourcing.
Sate of Good Repair Mitigation Plan
Asset Identification and Prioritization
Asset Management Strategy Optimization
Failure Analysis and FMEA
Key Performance Indicators (KPIs)
Lagging KPIs Measurement and Trending
Action Plan Development
Effectiveness Evaluation
Periodic Reviews and Continuous Improvement
Quality Audits to assess compliance state with regulatory requirements.
Professional evaluation of Quality Systems robustness