Zigzag Associates
ZigZagQA is a global leader in pharmaceutical, biotechnology, medical device, and clinical research quality assurance services. With a mission to constantly improve quality for better outcomes, they offer comprehensive GxP auditing and QA services across all good practice areas. Their expertise spans over 15 years, serving more than 200 clients worldwide, with offices in the UK, USA, Singapore, and a new location in California, USA. They have a certified women-owned status, a highly experienced team, and a commitment to global reach and tailored support to reduce risk and enhance capabilities.
Industries
Nr. of Employees
small (1-50)
Zigzag Associates
Reading, Reading, United Kingdom, Europe
Services
Tailored audits across GCP, GVP, GMP, GDP, GLP, GCLP and CSV frameworks delivered to assess compliance, identify gaps and support regulatory readiness.
Audits of investigator sites, clinical vendors, documentation, systems and clinical data processes to support ethical conduct and data integrity in clinical trials.
Evaluation and validation of regulated IT systems including risk management, IQ/OQ/PQ testing, security, infrastructure qualification and vendor assessments; includes training and remediation support.
Audits of manufacturing facilities and associated quality systems, including qualification audits, CAPA and change control oversight to support compliant product manufacturing.
Third‑party audits of nonclinical and clinical laboratories covering SOPs, study conduct and reporting, sample handling, equipment and personnel qualifications across specialized laboratory disciplines.
Assessment of distribution networks and storage providers to confirm environmental controls, traceability and compliance with international distribution requirements.
Tailored audits across GCP, GVP, GMP, GDP, GLP, GCLP and CSV frameworks delivered to assess compliance, identify gaps and support regulatory readiness.
Audits of investigator sites, clinical vendors, documentation, systems and clinical data processes to support ethical conduct and data integrity in clinical trials.
Evaluation and validation of regulated IT systems including risk management, IQ/OQ/PQ testing, security, infrastructure qualification and vendor assessments; includes training and remediation support.
Audits of manufacturing facilities and associated quality systems, including qualification audits, CAPA and change control oversight to support compliant product manufacturing.
Third‑party audits of nonclinical and clinical laboratories covering SOPs, study conduct and reporting, sample handling, equipment and personnel qualifications across specialized laboratory disciplines.
Assessment of distribution networks and storage providers to confirm environmental controls, traceability and compliance with international distribution requirements.
Expertise Areas
- GxP auditing and compliance
- Regulatory inspection readiness
- Quality management systems (QMS) implementation
- Computerized system validation (CSV)
Key Technologies
- Computerized system validation (CSV)
- AI and machine learning in regulated systems
- Cloud infrastructure qualification
- Electronic records and e‑signatures systems
News & Updates
ZigZagQA opens a new office in San Mateo, California, to serve the West Coast U.S. market, enhancing their ability to support pharmaceutical research and development.
Felix Böhles appointed as CFO to lead financial strategy and expand global footprint.
Marieke Kirkman appointed as CCO to lead market expansion and revenue growth.
ZigZagQA opens a new office in San Mateo, California, to serve the West Coast U.S. market, enhancing their ability to support pharmaceutical research and development.
Felix Böhles appointed as CFO to lead financial strategy and expand global footprint.
Marieke Kirkman appointed as CCO to lead market expansion and revenue growth.
ZigZagQA opens a new office in San Mateo, California, to serve the West Coast U.S. market, enhancing their ability to support pharmaceutical research and development.
Felix Böhles appointed as CFO to lead financial strategy and expand global footprint.
Marieke Kirkman appointed as CCO to lead market expansion and revenue growth.
ZigZagQA opens a new office in San Mateo, California, to serve the West Coast U.S. market, enhancing their ability to support pharmaceutical research and development.
Felix Böhles appointed as CFO to lead financial strategy and expand global footprint.
Marieke Kirkman appointed as CCO to lead market expansion and revenue growth.