Preclinical QMS
You do not need a complex clinical QMS while your product is still in preclinical development. But waiting until your first clinical trial is approaching can leave you trying to establish processes, organise historical documentation and prepare your organisation for GCP at the same time.
WHAT YOU NEED
Build your quality foundation before clinical development.
The OZQA Preclinical QMS provides a practical quality management system designed specifically for early stage biotech and pharmaceutical companies. Start with the processes that matter today. Add the clinical modules when your development programme progresses.
Starting your QMS journey?
Build the essential quality foundation with our Preclinical Core package.
Ideal for:
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Early stage biotech and pharmaceutical companies
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Companies preparing for future clinical development
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Organisations establishing their first structured QMS
Establish the core quality processes you need today, with a scalable foundation ready to expand as your development programme progresses.
THE PRECLINICAL QMS MODULES
A QMS designed for preclinical development.
A traditional pharmaceutical QMS can contain dozens of SOPs covering activities that an early stage biotech company may not perform for several years. OZQA takes a different approach. Our Preclinical QMS focuses on the core quality processes that are relevant during early development, while creating a structure that can later be expanded into a clinical Sponsor QMS.
Defines the structure, scope and principles of your Quality Management System.
Provides a structured approach to selecting, qualifying and overseeing CROs, laboratories, consultants, CDMOs and other external partners.
Establishes how controlled documents are created, reviewed, approved, updated and maintained.
Build a documented Quality training process with ready made training SOPs, competency records, training matrices and supporting templates.
Introduces a systematic approach to identifying, evaluating and managing quality and development risks.
Defines how important development and quality records are retained, protected and made retrievable throughout the development lifecycle.
SPONSOR BIOTECH COMPANIES
Designed for small and virtual biotech companies.
Early stage pharmaceutical development is increasingly outsourced. A biotech company may have only a small internal team while critical development activities are performed by CROs, laboratories, CDMOs, consultants and academic partners. Outsourcing the activity does not remove the need for oversight.
Your organisation still needs to understand:
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Who is responsible?
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Which activities have been outsourced?
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How are suppliers selected and evaluated?
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Who reviews critical documentation and data?
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How are development decisions documented?
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How are changes and risks controlled?
The OZQA Preclinical QMS helps establish this structure without introducing processes that are not yet relevant to your organisation.
WHAT YOU NEED
Build your quality foundation before clinical development.
The OZQA Preclinical QMS provides a practical quality management system designed specifically for early stage biotech and pharmaceutical companies.
Start with the processes that matter today. Add the clinical modules when your development programme progresses.
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DEVELOP ALONGSIDE YOUR PRODUCT
Start simple. Scale when you need it.
As clinical development approaches, your Preclinical QMS can be expanded with the OZQA Phase I/II QMS Module.
This allows your organisation to establish quality gradually rather than implementing an entire clinical QMS immediately before your first trial.
Pharmaceuticals
Moving from preclinical development into your first clinical trial represents one of the most significant changes in quality requirements for a biotech company. The OZQA pharmaceutical QMS framework is modular, allowing you to build on the same quality foundation as your development programme progresses.
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.
READY TO USE QUALITY CONTENT
Documents are only the beginning.
Start with our templates and add as much implementation support as your organisation needs.
BUILT TO WORK TOGETHER
Not just individual templates.
Our products are developed as parts of connected Quality processes. Procedures define how the process works and forms capture the required evidence, and related processes connect one document with the wider QMS.
WHY QMS
Why start your QMS during preclinical development?
Starting early gives your organisation time to learn how to work within a quality system before clinical development begins. It can help you:
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Create traceability
Maintain a clear history of important development activities and decisions.
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Control outsourced activities
Establish clear expectations and oversight of CROs, CDMOs and other partners.
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Protect development knowledge
Keep critical information within your organisation rather than relying solely on external providers.
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Build quality into everyday work
Allow your team to become familiar with controlled documents, training, risk management and change control.
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Prepare for clinical development
Create a foundation that can be expanded as GCP and additional regulatory requirements become relevant.
GXP DEVELOPED STANDARDS
Built by life science QA professionals
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. Whether you are developing your first therapeutic candidate or preparing to move towards clinical development, we help you implement the level of quality management that is appropriate for where you are today.
 GMP |  GVP |
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 GCP |  GDP |
FREQUENTLLY ASKED QUESTIONS
FAQ
Building a Quality Management System during preclinical development often raises practical questions. How much QMS do you actually need? Which SOPs should be implemented first? Do you need an electronic QMS? And what happens to the system when your first clinical trial approaches?
The right answer depends on your development stage, organisation, outsourced activities and regulatory roadmap. A preclinical QMS should therefore be proportionate to the activities you perform today, while providing a foundation that can grow with your organisation.