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.
On-Site and Virtual Third-Party and MOCK Audits
FDA and Global Regulatory Agencies Compliance Assessments
Third-Party Assessment, Remediation Plans Development, Workstreams design and Plan Execution
Site Inspection Readiness & Enhancement Plans
Third-Party Oversight:
Oversight Protocols creation
Oversight execution
Metrics tracking & Reporting
Mentoring
Certification
Compliance Management Strategies
Data Integrity and DIRA (Data Integrity Risk Assessments)
Quality Culture and Sustainability of Compliance
Quality Key Behaviors Indicators (KBIs) Assessment/Development
Quality Communications Plan Design
Investigations Back-log resolution & CAPA’s Effectiveness
Root Cause Analysis
SOP’s Simplification
Records Management & Document Controls System Management
Storyboard creation and Improvement
Scientific and Technical Assistance (Process, Laboratory, Packaging Operations)
Quality Systems Enhancement:
Analysis
Streamlining
Simplification
Quality Management System Development
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
PMO Services
Project Plans & Project Management Tools
Progress Metrics, Reporting and Dashboards
Risk Evaluation, Risk Assessment and Risk Heat Mapping and Risk Mitigation
Milestones & Resource Loading
Change Management Process
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.
Start Up Product Transfer Support
Tech Transfer Strategy
Process Development, Characterization, Engineering Studies, Stability runs, registration runs
Product and Method Transfer Support:
Protocols
Execution
Reporting
Process Performance Qualification; Process Validation
Support regulatory agencies changes filing & registration
Scale Up & 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
Training & Mentoring
Skill Enhancement
Coaching
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