QUALITY & COMPLIANCE
PRACTICAL QUALITY SUPPORT FOR REGULATED LIFE-SCIENCE ENVIRONMENTS
PHA FARMED supports pharmaceutical, biotechnology, medical device and healthcare companies in establishing, maintaining and improving quality systems aligned with applicable regulatory requirements and industry standards.
Our senior experts provide pragmatic, risk-based support tailored to the organisation, product and stage of development.
QUALITY MANAGEMENT SYSTEMS
Development, implementation and improvement of practical quality management systems tailored to regulated life-science activities.
- QMS development and implementation
- SOP preparation and review
- Quality documentation
- Roles and responsibilities
- Quality system optimisation
AUDITS & COMPLIANCE
Independent assessment of quality systems, processes and partners to identify compliance gaps and improvement opportunities.
- Internal and supplier audits
- Gap assessments
- Audit preparation and follow-up
- CAPA support
- Inspection readiness
GxP & ISO SUPPORT
Quality and compliance support across relevant GxP and ISO frameworks.
- GMP and GDP support
- GCP quality support
- ISO 9001 support
- ISO 13485 support
- Training and quality awareness
Need practical support with quality or compliance?
Let’s discuss how PHA FARMED can strengthen your quality system and support your compliance objectives.