OZQA

Quality & Compliance
for

Regulated Industires

OZQA helps regulated companies build, improve and operate practical quality systems without the complexity, long timelines and unnecessary consultancy hours.

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Pharmaceuticals

From preclinical research to marketed pharmaceuticals.

Cosmetics

From product development to compliant launch.

Medical Device

From innovation to a compliant medical device organisation.

Other Industries

Better systems. Better processes. Ready for certification.

START WHERE YOU ARE

Three ways to build a better QMS.

The OZQA QMS provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.

PRODUCTS

Ready made Standard Operating Procedures provide the overall framework for document and record management, including responsibilities, document lifecycle controls, approval requirements, version management and retention.

DOCUMENTS

Build it yourself

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PRODUCTS

QMS PACKAGES

Start with the full framework

A functioning QMS requires more than SOPs. The package therefore includes relevant supporting documentation to help put the procedures into practice. The documents are designed to work together as one QMS rather than as isolated templates.

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SERVICES

Growing organisations often need Quality expertise long before they need a full internal Quality department. OZQA solutions gives you flexible access to experienced specialists as your needs change.

Quality Solutions

Get expert support

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Stop paying consultants to start from a blank page.

THE OZQA WAY

Many quality requirements are standard. Your organisation is not. We start with proven frameworks, established documentation and practical implementation methods, then customise what actually needs to be customised.

We do not reduce quality to reduce cost. We reduce unnecessary work.

REGULATORY STANDARDS

Built around recognised quality and regulatory frameworks.

OZQA combines practical quality and regulatory experience with ready to implement QMS documentation. Our approach is designed for organisations that need a compliant and scalable quality framework without building unnecessary complexity into their operations.

BUILT FOR YOUR NEXT MILESTONE

Wherever you are, we help you move forward.

Quality requirements evolve as products, organisations and regulatory responsibilities develop. What is appropriate before a first clinical trial may no longer be enough at Phase III, just as a MedTech company preparing its first Quality system will have very different needs from one approaching certification or market launch.

Pharmaceuticals

OZQA helps you identify what your organisation needs now, while building with the next milestone in mind. Explore the journey for pharmaceuticals to see how Quality systems, documentation, oversight and compliance typically evolve as you move forward.

Preclinical

Move from having procedures to operating them consistently. Strengthen oversight, documentation, training and Quality governance as clinical activities and external partnerships increase.

Phase I & Phase II

Move from having procedures to operating them consistently. Strengthen oversight, documentation, training and Quality governance as clinical activities and external partnerships increase.

Bring together the documentation needed to support product safety, ingredients, manufacturing, claims and regulatory compliance. Ensure regulatory, product and Quality documentation is aligned before commercial distribution begins.

EU PV

Quality does not end at approval. Maintain oversight, pharmacovigilance, supplier control, CAPA, audits and continuous improvement throughout the product lifecycle.

Phase III

Ensure Quality systems, governance and documentation are mature enough to support late stage development and the transition towards regulatory submission and commercial operations.

MAH

Prepare the organisation for the transition from development into marketed product responsibilities, including ongoing Quality oversight, pharmacovigilance and relevant commercial Quality processes.

Cosmetics

OZQA helps you identify what your organisation needs now, while building with the next milestone in mind. Explore the journey for your industry to see how Quality systems, documentation, oversight and compliance typically evolve as you move forward.

Concept

Clarify product positioning, ingredients, intended claims and market requirements early to reduce avoidable compliance issues later in development.

Development

Create the documentation and Quality activities needed as formulation, suppliers, manufacturing and product claims develop.

Safety

Bring together the documentation needed to support product safety, ingredients, manufacturing, claims and regulatory compliance.

Market

Manage product changes, complaints, safety information, suppliers and ongoing documentation throughout the commercial lifecycle.

Registering

Get help registering your products according to current European regulatory cosmetics regulation.

Medical Devices

OZQA helps you identify what your organisation needs now, while building with the next milestone in mind. Explore the journey medical devices to see how Quality systems, documentation, oversight and compliance typically evolve as you move forward.

Design

Understand the intended use, regulatory pathway and Quality implications early enough to avoid expensive redesign or documentation gaps later. Establish practical design controls, risk management, documentation and responsibilities that support product development rather than slow it down.

ISO

13485

Establish practical design controls, risk management, documentation and responsibilities that support product development rather than slow it down.

EU MDR

& CE

Create traceability between requirements, design outputs, risks and verification and validation activities so the organisation can demonstrate that the product performs as intended.

Clinical

Evaluation

Assess the QMS, close remaining gaps, conduct internal audits and management review and prepare employees and documentation for certification activities. Support the organisation during the certification process and help manage questions, findings and follow up activities efficiently.

PMS & Vigilance

Ensure production, supplier, complaint, change and Quality processes continue to operate after the product enters the market. Connect complaints, post market surveillance, risk management, CAPA and product changes so information from the market drives continued product safety and improvement.