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Services

Quality Management Systems Installation & Compliance Consultancy

  • ISO 9001 Quality Management System
  • ISO 13485 Medical Devices Quality Management System
  • IATF 16949 Automotive Quality Management System
  • MDR (Medical Device Regulation) Compliance Consultancy
  • VDA Standards & Audit Preparation
  • FDA Regulations & Compliance Management
  • UKCA Certification Processes
  • GMP (Good Manufacturing Practices) Consultancy
  • GDP (Good Distribution Practices) Consultancy
  • GCP (Good Clinical Practices) Consultancy

Product Development Consultancy

  • Automation-oriented machine and line design for pharmaceutical, cosmetic, dietary supplement, and medical device industries
  • Enhancement and optimization of product quality standards
  • Innovative product design and development processes
  • Chemical formulation development and optimization
  • Product development based on clinical and manufacturing risk analysis
  • Product labeling and marketing strategy development

Manufacturing Facility & Production Line Installation Services

  • Product-specific, flexible production line design
  • Cost-effective manufacturing and warehouse area design in compliance with regulations
  • Design and installation of industrial facility systems including HVAC, purified water, inert gas, and compressed air

    • Process Validation Planning & Reporting Consultancy

  • Validation Master Plan (VMP) Preparation
  • URS, FAT, SAT, and DQ Design Qualification
  • Equipment Qualification (IQ, OQ, PQ) Protocols and Reporting
  • Process Validation Protocol Design and Summary Reporting

    • FDA Facility Registration & US Agent Services 

    • FDA Facility Registration Procedures
    • Official US Agent Services

    MDR CE Certification

    • MDR (2017/745) Compliant CE Certification Consultancy
    • Technical File Preparation and Notified Body Process Management

    Production Efficiency Consultancy

    • OEE (Overall Equipment Effectiveness) Calculation and Efficiency Analysis
    • Strategic supply chain and warehouse organization management
    • Advanced production planning and process optimization

    Laboratory Installation & Equipment Procurement Services

    • Turnkey laboratory installation services
    • Procurement and integration of industrial laboratory equipment

    Risk Analysis & Risk Management Consultancy 

    • ISO 14971 (Risk Management for Medical Devices) Applications
    • ISO 24971 Guidance Standards Compliance Consultancy

    Corporate Training Services 

  • Quality Management Systems Trainings
    • ISO 9001:2015 QMS Foundation, Documentation, and Internal Auditor Training
    • ISO 13485:2016 Medical Devices QMS and Internal Auditor Training
    • IATF 16949 Automotive QMS Awareness Training
  • Regulation and Legislation Trainings
    • MDR (2017/745 Medical Device Regulation) Foundation and Practical Application Training
    • FDA Regulations and US Market Entry Strategies Training
    • CE Marking Processes and Technical Documentation Preparation Training
  • Good Practice Standards (GxP) Trainings
    • GMP (Good Manufacturing Practices) Foundation and Advanced Training
    • GDP (Good Distribution Practices) and Supply Chain Security Training
    • GCP (Good Clinical Practices) and Clinical Trials Training
  • Engineering, Validation, and Risk Management Trainings
    • ISO 14971 Risk Management for Medical Devices Training
    • Cleanroom Classification and Management Training
    • Process Validation and Qualification (IQ/OQ/PQ) in Production Lines Training
    • OEE and Lean Manufacturing Techniques for Efficiency Improvement Training

    • Clinical Research Documentation Consultancy 

    • GCP (Good Clinical Practices) Compliance Services
    • Clinical Research Protocol Preparation
    • Clinical Study Planning and Methodology
    • Clinical Study Quality Assurance
    • CIP (Clinical Investigation Plan) Documentation
    • CIR (Clinical Investigation Report) Preparation
    • PSUR (Periodic Safety Update Report) Preparation
    • CEP (Clinical Evaluation Plan) Preparation
    • PMCF (Post-Market Clinical Follow-up) Process Management
    • PMS (Post-Market Surveillance) Planning and Reporting
    • CER (Clinical Evaluation Report) Preparation