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.