Global Life Sciences Quality
Audit & Compliance Consultancy
Exclusively focused on Strategic Value Creation
We leverage extensive experience and provide robust technical expertise, paired with a tailored facilitation approach, to achieve the specific objectives of our partners.
Continuously, we observe the profound impact of our distinctive dual approach, focusing on technical processes Simplification and human Facilitation, in consistently fostering exceptional results, both technically and interpersonally.
we are dedicated to ensuring that our customers receive at least the double value of their investment.
our pricing reflects the proportional added value we provide.
What are the core intervention topics we specialize in?
Quality Assurance Systems, Operations, and Regulatory Compliance
Comprehensive Risk Assessment Across All Levels
Qualification and Management of Raw Materials, Suppliers, and CDMOs (Contract Development and Manufacturing Organizations)
Pharmaceutical Technology Transfer
Medical Device ISO 13485: Implementation and Auditing
Global Quality Commercial Operations : Creation, Support, Supervision and Management of Affiliates at Global Headquarter.
Internal and External Audits, EU and FDA Inspections Readiness
Project Management and Facilitation: Orchestrating Success
Deviation, Change Control, Complaint, Corrective and Preventive Actions (CAPA), and Key Performance Indicators (KPIs)
Computer System Validation (CSV)
Good Distribution Practices (GDP)
