About OZQA

OZQA provides turnkey Quality Management Systems (QMS), ready-to-use SOP templates, and implementation services for biotech, pharma, and life science companies.

We help organizations simplify GxP compliance and achieve inspection readiness faster.

No, not necessarily. OZQA also supports early-stage companies that may not yet have a full quality function in-house. Our SOPs are simple to apply and tailored for lean teams or solo founders.

Implementation typically takes 3–6 weeks, depending on the scope and number of documents.

We design every project to reach inspection readiness as efficiently as possible.

Yes. The SOPs come with editable action lists and templates, allowing you to tailor them to your company's operations while remaining fully compliant.

Absolutely. The system is built to help you demonstrate a functioning QMS during an inspection. We help you ensure everything is signed, implemented, and ready for review.

Each SOP template is pre-filled, written by QA professionals, and aligned with EMA, FDA, and ICH GxP guidelines.

Templates include standardized sections such as purpose, scope, responsibilities, procedure, and references — all in editable Word format.

Yes. All templates are fully editable and can be tailored to your internal processes, terminology, and roles.

If you need help adapting them, our Service Packages include guided implementation and support.

The Basic Package focuses on QMS implementation — setting up your documentation, structure, and control.

The Premium Package adds training sessions and assistance to help your team maintain compliance independently.

Our Full QMS Solution includes all SOPs, log forms, system setup, training, and support — ready for EMA/FDA inspection.

It’s a complete, turnkey system tailored to your organization.

Absolutely. You can buy single SOPs or log forms directly from our template catalog.

Each document can be downloaded immediately and later integrated into a larger QMS setup.

Yes — all documents are aligned with GxP, ICH, EMA, and FDA expectations for documentation and quality systems.

They’re designed to pass audits and inspections without additional rewriting.

All documentation is developed by QA professionals with real experience from biotech, clinical, and pharmaceutical companies.

Our team has supported both early-phase and commercial-stage organizations through audits and regulatory submissions.

Yes. Through our Premium Service Packages and Full QMS solution, we include support for SOP editing, training modules, and document optimization.

We can also help integrate your documentation into electronic QMS platforms.

Yes. OZQA serves clients across Europe, USA and worldwide.

All templates and systems are designed according to internationally recognized GxP standards and can be adapted to regional requirements.

You can start by:

1. Purchasing templates directly through our webshop, or

2. Contacting us to discuss your QMS needs.