QUALITY MANAGEMENT

Business & Quality Management System

Gap Analysis and Due Diligence

Target & KPI Process

Internal and external audits

CAPA & 8D Management

Implementation of requirements

SUPPLIER MANAGEMENT

Quality Assurance of Suppliers and Contract Manufacturers

Supplier Performance Management

Supplier Audit Process

Supplier Quality Assurance in R&D phase and in production phase

VIGILANCE MANAGEMENT

Customer Complaints Handling

Adverse Events

Field Safety Corrective Actions (FSCA), including recalls

Communication with authorities

Post Market Surveillance