Pharmaceutical & Medical Device
Quality Management Consulting
12+ years of hands-on expertise implementing Quality Management Systems for regulated life sciences companies worldwide — from quality process design to system validation and TrackWise implementations and upgrades.
12+
Years of QMS Expertise
70
Pharmaceutical Customers
34
TrackWise Digital Customers
12
Countries Worldwide
End-to-End Quality &
Technology Solutions
Specialist consulting for the pharmaceutical and life sciences industry — combining deep QMS expertise with modern software development.
Quality Management Systems
Over 12 years implementing quality processes at world-leading pharmaceutical companies — change control, complaints, deviations, investigations, audits, and supplier quality.
- Change Control
- Complaints Management
- Deviations & CAPA
- Supplier Quality Management
- Audit Management
Salesforce Development
Certified Salesforce ISV Partner. Custom object development, Lightning Web Components, APEX programming, configuration migrations, and end-to-end automation.
- Lightning Web Components
- APEX Programming
- Custom Objects & Flows
- Data Migration
- Automation Workflows
TrackWise QMS Solutions
Expert support for cloud-based (Salesforce) and on-premise TrackWise deployments — version upgrades, validation, module configuration, and user training.
- Version Upgrades
- Validation Support
- Module Configuration
- Web Services & SAML
- User & Admin Training
Hemeralis QMS
A cloud-based, compliant Quality Management System designed for small and mid-size pharmaceutical and biotech companies.
Built from the ground up with compliance at its core — GxP, 21 CFR Part 11, and GDPR compliant from day one. Affordable, vendor-operated, purpose-built for life sciences.
Audit Management
Complete audit planning and execution — internal and external workflows, findings management, and compliance-ready reporting.
CAPA Module
Full corrective and preventive action lifecycle, from audit findings through root cause analysis to effectiveness verification.
21 CFR Part 11 e-Signatures
Legally compliant electronic signatures with two-factor authentication and a complete, tamper-evident signature chain.
GxP Audit Trail
Hash-chained, append-only audit log providing tamper-evident records for regulatory submissions and GxP audits.
12+ Years in Pharmaceutical Quality & Technology
GÜNES CONSULTING OÜ has over 12 years of hands-on experience defining and implementing Quality Management Systems at world-leading pharmaceutical companies — spanning change control, complaints management, deviations, investigations, CAPA, audits, and supplier quality.
We combine that depth of QMS expertise with certified Salesforce development capabilities, delivering compliance-ready solutions tailored to the real constraints of small and mid-size pharma and biotech organisations.
Our clients include pharmaceutical manufacturers, biotech companies, and medical device organisations across Europe, the United States, and Latin America.
12+
Years of QMS Expertise
Pharma
& Biotech Focus
EU · US
& LATAM Clients
GxP
Compliance-First
A Global & Multilingual Partner
Serving clients across Europe, the United States, and Latin America — working seamlessly across languages and regulatory frameworks.
Let's Work Together
Ready to improve your quality management processes or implement a QMS solution? Send a message — we respond within one business day.
Message sent.
Thank you — we'll respond within one business day.