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​LEF’s experience in several areas as led to a body of knowledge which we share with our clients and partners, supporting the implementation and management of Quality Systems, including customized training sessions.

  • Quality Systems Development, in accordance with GMP, GLP, GDO, ISO 17025 and ISO 9001 requirements;
  • Preparation for regulatory inspections and clients audits;
  • Development of customized training programs (GXP and ISO standards);
  • Internal audits for GMP, GLP, GDO and ISO regulations compliance;
  • APIs’ Suppliers, finish product manufacturers, excipients manufacturers and packaging materials suppliers audits according to:
    • GMP
    • GDP
    • ISO 9001
    • ​ISO 17025
  • Consultancy for validation (cleaning, manufacturing processes and analytical methods);
  • ​Preparing the Site Master File and other GXP documents.