Biomed & Pharma

  • Establish and maintain international management system standards;

  • Implement a sustainability management system standards;

  • Assess regulatory and voluntary compliance of process & product;

  • Support for accreditation of testing laboratories.

Consulting Services

  • Management System Standards Design, Development & Maintenance;
  • Compliance with process & product standards;
  • Integrated Management System;
  • Risk Estimation, Evaluation, Control and Monitoring;
  • Awareness, Training and Education;
  • Facility Security Assessment;
  • Trucking security Assessment;
  • Monitoring and Control;
  • Internal and Second-Party Auditing;
  • Regulatory Upgrade and Design the Incorporating Activities;
  • Labelling;
  • Process Improvement Tools.

Reference Standards

  • Management Systems: ISO 9001, ISO 14001, OHSAS 18001, ISO 27001, ISO 50000, EMAS, ISO 37001, ISO 28000; UNI 10617, ISO/TS 16949, IRIS and ISO 9100;
  • Accreditation of Testing laboratories: ISO/IEC 17025;
  • Inspection and Supply Chain Audit and Management: ISO/IEC 17020 and tailor-made standards;
  • Regulatory Standards: Medical devices CE mark, ISO 13485, Construction product CE mark, ISO 22716, ADR and ADR packaging compliance, FDA food integrator and cosmetics, Aerosol test, GDPR, REACH, Safety sheet Card; D.LGS 231/01, Reference document (FARMINDUSTRIA ed. 2015) for the certification of procedures related to scientific information activities; EN 15593;
  • Process and Product Standards : BRC, IFS, ISO 22000, FFSC 22000, NATRUE, COSMOS, EFFCI, Tailor-made processes and product standards;
  • Sustainability Standards (environmental): Biodegradation and compostability products according EN 13432, Water food print, Carbon foot print (product and organization), Swedish EPD, Remade in Italy, LCA standard, FSC and PEFC, RSPO;
  • Sustainability Standards (enterprise-level): SA 8000, ISO 26000, Global Report Initiative (GRI), UL 880.