You are a biotech/ pharmaceutical company, a contract research organization, or a vendor. You want to organize and conduct an audit, and you need independent external resources? We can help you!
We will help to improve the existing program of auditing, make it productive and based on real risks
We can conduct and investigational site audit
We can audit a vendor (for example, a CRO, IMP warehouse, investigational laboratory etc.)
We can audit the Trial Master File
We can conduct any type of GxP audit in any place in Eurasia
Our team has performed about 200 GxP audits in EU, CIS, and Africa
We are fluent in 4 languages
Key experts in clinical trials conduct, quality assurance, quality control, and auditing, members of the British Association of Research Quality Assurance (RQA)
Independent GCP consultant
QA consultant, trainer (TMQA), with significant experience in audits and inspections of investigational sites in different countries worldwide, as well as practical experience in the construction of quality management systems for CROs and sites
R&D Head in Maxwell, a Russian company, with significant experience in product development, studies conduction, auditing, construction of quality assurance systems.
Clinical research quality assurance manager in one the largest global pharmaceutical companies
Clients relay on us
Book a service
Send us a message if you plan an audit or want to book consulting service