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    • Experts in Cross-Contamination
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    • ICH Q3D Implementation – Elemental Impurities
    • Analytical Development
    • Project Management
    • Medical Cannabis
    • GxP Global Solutions
  • Medical Devices
    • CE Marking: technical and regulatory aspects for its application.
    • Quality System EN ISO 13485: 2016
    • VALIDATION OF SOFTWARE AND APPS
    • POSTCOMERCIALIZATION FOLLOW-UP
    • COMMERCIALIZATION IN USA – FDA REQUIREMENTS
  • CSV
    • Data Integrity
    • Computerized Systems Validation
    • Systems Evaluation and Action Plans
    • Development of IT Quality System, Policies and Procedures
    • Support to Systems Developers
    • Serialization
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    • Risk Assessment on Transportation Routes
    • Cold Chain Assessment: Temperature Mappings
    • Logistics Operators Audits
    • Clients Qualification: Pharmacies, Wholesalers and Hospitals
    • GDP Training Courses
    • Implementation of GDP Quality System
    • Implementation of Measures to avoid Drugs Counterfeiting
    • Implementation of Cost-Saving Measures
    • Validation of Transportation Routes
  • Qualifications
    • Clean room qualification (HVAC)
      • Environmental Control in Clean Rooms (HVAC System) and Laminar Flows
      • Microbial Test in Compressed Air / Gas Equipment
      • Maintenance and Qualification of Safety Cabinets, fume hoods and Isolators
      • Cross-Contamination: Environmental Verification
    • Qualification of Particle Counters Monitoring Installations
    • Thermal equipment qualification
      • Temperature Mappings in Autoclaves
      • Temperature Mappings in Freeze drying, Autoclaves, Tunnels and Sterilization Ovens
      • Mappings in Temperature Controlled Equipment: Drying Oven, Incubators, Freezers, Ultra Low Temperature Freezers
      • Temperature Mappings of Warehouses, Storage Areas and Vehicles
    • GMP Fluids Qualification
    • CIP/SIP Cleaning System Qualification
    • Production equipment qualification
    • Analytical Instruments Qualification
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    • Validation of Reception, Storage and Dispatch Process
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Validations


Cleaning validation

Cleaning validation

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Validation of Reception, Storage and Dispatch Process

Validation of Reception, Storage and Dispatch Process

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Production Process Validation

Production Process Validation

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Analytical Methods Validation

Analytical Methods Validation

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Computerized Systems Validation

Computerized Systems Validation

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Pharmaceutical Process Validation

Pharmaceutical Process Validation

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