AUDIT SERVICES | TECHNICAL & REGULATORY SERVICES | QUALITY SERVICES | TRAINING SERVICES | VALIDATION SERVICES

supervised and coordinated by:

Dr. Antonio Visconti (*)

cGMP & FDA Regulatory Affairs Advisor
Qualified Person (QP)

(*)  25  YEARS  OF  PHARMACEUTICAL  INDUSTRY EXPERIENCE  IN QUALITY  ASSURANCE,  QUALITY COMPLIANCE, QUALITY CONTROL AND PRODUCTION IN FDA, EMEA, AND WHO REGULATED INDUSTRIES IN DIFFERENT COMPANIES, LOCATIONS AND CULTURES.

Audit Services

We support our clients in key-decisions process on their suppliers based on risk. We help our clients in preparation for regulatory inspections with a range of scenario-based Inspection Readiness Programs (IRP):

  • Active Pharmaceutical Ingredient(API)
  • Contract Manufacturing Organization (CMO) audit
  • Data Integrity
  • Packaging
  • Pre-Inspection Preparation (MHRA/FDA/EMA/ANVISA/ISO)
  • Gap Analysis
  • Remediation Activity Auditing
  • GMP/GDP
  • Computer System Validation
  • Intra Company Auditing
  • Commissioning & Qualification (C&Q ) Planning, Development and Execution
  • CSV Planning, Requirements, Functional and Design Specification, Final Reports
  • Development and Execution of Testing Protocols (FAT, SAT, IQ, OQ, PQ)
  • Traceability Matrix, Master Document Lists

Quality Management Services

We provide extensive experience in redesigning quality management systems in line with our clients ’

needs and regulatory requirements, to improve client performance. A few key services in our Quality

Systems portfolio are, but not limited to:

  • Deviation & CAPA Management & Improvement
  • Post-Inspection CAPA Support & Management
  • Change Control Process Update & Improvement
  • Remediation Support & Management
  • Facility Compliance Gap Assessment & Production Advice
  • Quality Documentation (SOP, Protocols, Reports, Simplified KPI Generation, etc)
  • Risk Assessment
  • Self-Inspection Management
  • Quality Assurance Support
  • EU QP Services
  • EU Batch Release
  • GDP Activities
  • Recall Management

Technical & Regulatory Services

We provide extensive experience in delivering technical projects for our clients. A few key services in our Technical portfolio are, but not limited to:

  • Regulatory Support
  • Remediation Activities
  • Project Management
  • Technology Transfer
  • Packaging Transfer
  • Temperature Mapping
  • Contamination Control
  • Stability Management
  • Validation (Process & Equipment Change)
  • Facility Design and Equipment Qualification
  • Production System
  • Packaging and Labelling

Training Services

We can create and provide a wide range of training packages that are custom-made to ensure you get the desired benefit. Our trainings are interactive to achieve the desired levels of understanding.

A few key services in our training portfolio are, but not limited to:

  • Good Manufacturing Practice (GMP)
  • Pharma Quality System (Deviation, Change Control, CAPA Process)
  • Good Distribution Practice (GDP)
  • Responsible Persons Training
  • Regulatory Compliance
  • Technology Transfer
  • Six-Sigma
  • Computer System Validation
  • Validation training (Equipment/Process)

Validation Services

We can support generation of all validation documentation (VMP, URS, FAT, SAT, DQ, IQ, OQ, PQ, Process

Validation, Method Validation, validation report) and perform gap assessment. A few key services in our validation portfolio are, but not limited to:

  • Validation Master Plan (VMP) Generation
  • Computer System Validation (CSV)
  • Validation Risk Assessment
  • Data Integrity
  • Cleaning Validation (Cross Contamination Risk Assessment)
  • Equipment Validation (Processing & Packing)
  • Process Validation
  • Method Validation
  • Validation Documentation
  • Revalidation Strategy
  • Validation Remediation Activities
  • Utilities Validation (HVAC, Purified Water, Compressed Air)
  • New Facility Qualification