Preclinical QMS Package
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.
QMS BEFORE CLINICAL DEVELOPMENT
Build a QMS on your own or with our help.
The OZQA Preclinical Complete QMS package and solution are designed for biotech and pharmaceutical companies that does not have a quality foundation in place. Choose to build your QMS by yourself or with help from OZQA's quality experts.
COMPLETE
PRECLINICAL
___
BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete preclinical QMS with an audit-ready documentation package.
Ideal for
Early stage organisations establishing their first structured QMS with internal QA resources to implement the package.
Package Includes
6 pre-written SOP's
9 ready to use log forms
€5.685
COMPLETE
PRECLINICAL
___
BUILD A QMS
WITH SUPPORT
Starting from scratch? Let OZQA's quality experts help you build a preclinical QMS with our pre-written GxP compliant documentation package.
Ideal for
For organisations that need to establish the full quality framework with support from OZQA's experts.
Package Includes
6 pre-written SOP's
9 ready to use log forms
Customisation
Implementation
5 h. training
14 days support
€11.950
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.
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.
Documents included in the complete package
Outsourcing the activity does not remove the need for oversight. Your organisation still needs to understand:
Who is responsible?
Which activities have been outsourced?
How are suppliers selected and evaluated?
Who reviews critical documentation and data?
How are development decisions documented?
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.
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.
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.
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.
WHEN TO START BUILDING A 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 |
|---|---|
 GCP |  GDP |
CHOOSE WHAT YOU NEED
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.
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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.