DO YOU REQUIRE GXP CONSULTING BASED ON EXISTING STANDARDS?
We'll help you develop or improve your existing Quality Management System.
HOW WILL WE MAKE IT?
- EVALUATIONWe will evaluate the existing Quality Management System, determine missing elements and fields for improvement
(GAP analysis) and help you complete them. - TRAININGWe will train your employees
to understand systemic processes of the company, follow all procedures of the company increasing quality of your work. - DEVELOPMENTWe will develop, optimise, and help you implement Quality Management System, write, and check SOPs, working instructions and other quality documents by all GxP and QA sections considering your company’s characteristics, structure and rendered services.
- REWARDOur auditors will be glad to reward you with the fair number of objective findings and recommendations
OUR ADVANTAGES
-
EXPERTISE
We will perform all types of GxP audits
in accordance withICH-GxP guidelines (GCP, GCLP, GDP, GMP) including international (EMA, MHRA, FDA),
ISO 14155 (Medical Devices Clinical Investigations), and local regulatory requirements (European and CIS countries)
-
1000 + AUDITS
Our capacity includes but not limited
to audits of Investigators Sites, Quality Management System, TMF, vendors, documents, GLP, GCLP, GDP, etc
-
NO BORDERS
We speak four languages fluently
and our geography covers CIS countries, Europe, USA and Latin America, Asia, Africa and the Middle East