Quality assurance consulting

If you are a biotechnological, pharmaceutical company, contract research organisation, study site, or laboratory planning to enter the market of clinical and preclinical studies, then you should develop or improve the existing quality management system.

 We can definitely help you with it!

How will we make it?
We will evaluate the existing Quality Management System, determine missing elements
and fields for improvement
(GAP analysis) and help you complete them.
We will train your employees
to understand systemic processes of the company, follow all procedures of the company increasing quality of your work.
We 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.
Auditors and inspectors will
be glad to reward you with the minimum number of minor findings.
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).
500+ 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
They trust us
Contact us
Ul. Adama Branickiego 21 U3
Warsaw; Mazowieckie;
Postal Code: 02-972

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