Quality & Compliance Solutions for Life Science Companies

OZQA provides inspection-ready quality management solutions for pharmaceutical and medical device companies operating in regulated environments.

We support organisations with GxP, ISO 9001, ISO 13485, and EU Pharmacovigilance, combining structured documentation, practical consulting, and real inspection experience.

Our focus is on clear, proportionate, and usable quality systems, particularly for companies working with outsourced or lean operating models.

Pre-filled SOP Templates

Complete SOP package

€9,985.00

Excluding VAT

Two ways to work with OZQA

Inspection-ready quality systems and pharmacovigilance support for pharma and medtech. SOP templates, consulting, and QMS expertise covering GxP, ISO 9001, ISO 13485, and EU GVP.

QMS Documentation & Templates

Professionally written, pre-filled SOP templates and log forms designed to support compliant Quality Management Systems.

GxP SOPs for pharmaceutical companies
ISO-based documentation for medical devices
Log forms and registers supporting traceability and inspections
Audit-tested, inspection-ready structure

Document templates

Consulting & QA Support

Flexible consulting support provided on an hourly basis.

Pharmaceutical quality systems (GxP)

Medical device quality systems (ISO 9001 & ISO 13485)

Pharmacovigilance (EU GVP)

Audit preparation and inspection support

QA Consulting

Industries We Support

Pharma

Quality and compliance support across the pharmaceutical lifecycle, from early development to marketed products.

MedTech

ISO 9001 and ISO 13485 quality management support for medical device companies.

About Us

Resources

Two scientists, puzzled, stand by a scale with SOPs. Text: "Write & Re-Write," "Document or Do Science?" Background shows more SOPs.

Is the Life Science Industry Stuck in a Documentation Paradox?

In a time when biotech and medtech are moving faster than ever, one thing has barely changed in the last 20 years: documentation. SOPs, procedures, templates, and log forms form a foundation that should ensure consistency and compliance. But in many companies, it has instead become a bottleneck that slows progress and drains resources. An Invisible Bottleneck No One Talks About Ask startup founders and QA professionals behind closed doors, and the message is the same: Documen