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?
  • Evaluation
    We will evaluate the existing Quality Management System, determine missing elements
    and fields for improvement
    (GAP analysis) and help you complete them.
  • Training
    We will train your employees
    to understand systemic processes of the company, follow all procedures of the company increasing quality of your work.
  • Development
    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.
  • Reward
    Auditors and inspectors will
    be glad to reward you with the minimum number of minor findings.
  • 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).
  • 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