Quality & Processes (QA)

Quality assurance and process development for Life Science in the Nordics and EU.

About the service

Quality & Processes (QA)

MAx RegConsult offers support in quality assurance and process development - from building QMS to auditing, CAPA and change management.

We help Life Science companies create efficient, traceable and sustainable quality processes that fulfil both internal and regulatory requirements.

Quality system & documentation

Establishment, review and improvement of QMS, SOPs and work instructions according to GMP and GDP.

Deviations & CAPA

Investigation of non-conformities, corrective and preventive actions and implementation of improvements.

Risk management & change control

Quality risk assessment, process improvement and management of product life cycle changes.

Do you need support with quality and processes?

We help you build robust systems and procedures that ensure quality, compliance and safe delivery.