Consulting in the area of quality assurance
Consulting in the area of quality assurance
You are a biotech/ pharmaceutical company, a contract research organization, or a
vendor. You have just entered or are planning to enter the clinical trials market.
You need to develop or refine the existing quality management system. We can help you! How?
vendor. You have just entered or are planning to enter the clinical trials market.
You need to develop or refine the existing quality management system. We can help you! How?
We will assess what you already have and will think through what you really need to
create, develop and add in the quality area
create, develop and add in the quality area
We will develop and introduce the Quality Management System, write and proofread
SOPs, work instructions, and other quality documents on all GxP and QA sections,
taking into account the characteristics of your company, your services and structure
SOPs, work instructions, and other quality documents on all GxP and QA sections,
taking into account the characteristics of your company, your services and structure
We will optimize and improve the Quality Management System for your company
We will analyze the existing Quality Management System, define lacking
elements and areas to improve (GAP analysis) and help to fill the gaps
elements and areas to improve (GAP analysis) and help to fill the gaps
We will teach your employees to understand what they really need to do and to follow all
company procedures enhancing the quality of their work
company procedures enhancing the quality of their work
Auditors and inspectors will be glad to have minimal number of minor findings
New and existing clients will contract you for new interesting projects
Expertise
We can conduct any type of GxP audit in any place in Eurasia
200+ audits
Our team has performed about 200 GxP audits in EU, CIS, and Africa
No borders
We are fluent in 4 languages
Our team
Key experts in clinical trials conduct, quality
assurance, quality control, and auditing,
members of the British Association of
Research Quality Assurance (RQA)
assurance, quality control, and auditing,
members of the British Association of
Research Quality Assurance (RQA)
Maxim Bunimovich
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
different countries worldwide, as well as practical experience in the construction of quality management systems for CROs and sites
Dmitriy Manuilov
R&D Head
R&D Head in Maxwell, a Russian company, with significant experience in product development, studies conduction, auditing, construction of quality assurance systems.
Maria Leer
Manager
Clinical research quality assurance manager in one the largest global pharmaceutical
companies
companies
Clients relay on us
Book a service
Send us a message if you plan an audit or
want to book consulting service
want to book consulting service
