Global Pharma QA is a Limited Company (Ltd.) established and managed by Orit Galperin, M.Sc and Certified Quality Engineer (CQE).

We provide independent consultancy and auditing worldwide with a focus preparing companies for GLP/GCLP/ ISO15189 accreditations and regulatory inspections.

 

We also have intense experience consulting non-regulated companies and university labs for quality improvements.

Core services include Assessment of Compliance with applicable sections of the following directives and regulatory guidelines and Global Auditing:

  • GLP with OECD GLP or/and FDA 21CFR part 58, for Good Laboratory Practice for Nonclinical Laboratory Studies and part 11 for Electronic Records; Electronic Signatures. 

  • GCLP in central and reference laboratories EMA/RQA/WHO

  • We also audit according to country local GLPs as CFDA GLP (Chinese GLP), Brazilian GLP and more.

  • Wide experience auditing and consulting Universities and Research Centers for Good Research Practice.

We inspect and give GCLP Laboratories Compliance Certification - valid for 2 years

Additional regulatory needs can be assessed per client request.