GLOBAL LIFE SCIENCES QUALITY, COMPLIANCE AND AUDIT CONSULTANCY
DEDICATED TO COMPLEX PROJECTS AND STRATEGIC VALUE CREATION
WE LEVERAGE EXTENSIVE EXPERIENCE AND DEEP EXPERTISE TO ACHIEVE THE TECHNICAL, OPERATIONAL AND HUMAN OBJECTIVES OF OUR PARTNERS.
OUR DISTINCTIVE DUAL APPROACH COMBINES THE SIMPLIFICATION OF TECHNICAL AND ORGANIZATIONAL PROCESSES WITH STRONG HUMAN ENGAGEMENT, SUPPORTED BY EFFECTIVE FACILITATION, DRIVING EXCEPTIONAL RESULTS ACROSS TECHNICAL, OPERATIONAL AND HUMAN DIMENSIONS.
WE ARE COMMITTED TO GENERATING EXCEPTIONAL VALUE, CONSISTENTLY EXCEEDING THE INVESTMENT MADE BY OUR CLIENTS.
OUR CORE AREAS OF INTERVENTION
Quality Assurance Systems, Operations, and Regulatory Compliance
Comprehensive Risk Assessment Across All Levels
Qualification and Management of Suppliers, Raw Materials and CDMOs (Contract Development and Manufacturing Organizations)
Pharmaceutical Technology Transfer
Medical Device ISO 13485: Implementation and Auditing
Global Quality Commercial Operations: establishment, support, oversight and management of affiliates at global headquarters.
Internal and External Audits, EU and FDA Inspections Readiness
Project Management and Facilitation
Deviation, Change Control, Complaint, Corrective and Preventive Actions (CAPA), and Key Performance Indicators (KPIs)
Computer System Validation (CSV)
Good Distribution Practices (GDP)
SELECTED CLIENT REFERENCES
