Phase I & II QMS Package
Entering clinical development changes the quality responsibilities of a biotech or pharmaceutical company. As a clinical trial sponsor, you need more than controlled documents. You need a Quality Management System that supports sponsor oversight, clinical trial activities, service providers, safety, deviations, CAPA and regulatory compliance throughout the trial lifecycle.
A QMS FOR CLINICAL DEVELOPMENT
The OZQA Phase I/II Complete QMS package and solution are designed for biotech and pharmaceutical companies that does not have a quality foundation in place, and need to build a QMS to support Phase I and Phase II clinical development. Choose to build your QMS by yourself or with help from OZQA's quality experts.
Build a QMS on your own or with our help.
COMPLETE
PHASE I/II
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BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete clinical Sponsor QMS with a audit-ready documentation package.
Ideal for
Companies with established core quality processes and internal QA resources to implement the package yourself.
Package Includes
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13 pre-written SOP's
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15 ready to use log forms
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Step-by-step guide
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Implementation action log
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24/7 AI quality support
€9.985
COMPLETE
PHASE I/II
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BUILD A QMS
WITH SUPPORT
Starting from scratch? Let's help you build a complete QMS with our pre-written GxP compliant documentation. OZQA's experts can guide you all the way to audit-readiness.
Ideal for
For organisations that need to establish the full quality framework with support from OZQA's quality experts.
Package Includes
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13 pre-written SOP's
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15 ready to use log forms
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Step-by-step QMS guide
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Implementation action log
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24/7 AI quality support
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Quality assessment
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Custom implementation
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5 hours training
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14 days follow-up support
€19.950
THE PHASE I/II QMS MODULES
A QMS designed for clinical sponsors.
Phase I and Phase II share many of the same fundamental GCP sponsor responsibilities. Rather than creating separate quality systems for each clinical phase, OZQA provides a combined Phase I/II QMS documentation package that can scale as your clinical programme grows. The system builds on the core quality processes established during preclinical development and introduces the additional processes needed for clinical trial sponsorship.
SPONSOR BIOTECH COMPANIES
Sponsor oversight cannot simply be outsourced.
Many early stage biotech companies operate with small internal teams and outsource a significant proportion of clinical development. A CRO may manage the trial. A specialist vendor may manage clinical data. Another provider may perform pharmacovigilance activities. Clinical sites conduct the trial. But outsourcing activities does not remove the sponsor's responsibility for appropriate oversight.
Documents included in the complete package
Your QMS should clearly establish:
What has been delegated?
Who is responsible for each activity?
How are service providers selected and qualified?
How does the sponsor maintain oversight?
How are quality issues escalated?
How are risks identified and managed?
How does the sponsor know that delegated activities are being performed appropriately?
The OZQA Phase I/II QMS is designed with outsourced and virtual biotech operating models in mind.
FROM DOCUMENTATION TO IMPLEMENTATION
Implementation guide and action plan included.
The OZQA Phase I/II Complete QMS Package includes practical tools to guide the implementation of your entire QMS, from foundational Quality processes to clinical sponsor responsibilities.
QMS Implementation Guide
A step by step roadmap covering document control, training, sponsor oversight, risk management, change control, CAPA, product Quality, safety reporting and clinical compliance. The guide also addresses QMS activation, Go Live readiness and ongoing Quality Management throughout clinical development.
Become a free OZQA Quality Member to access the complete Implementation Guide, along with exclusive Quality guides, checklists and expert insights.
QMS Implementation Action Plan
Turn your roadmap into action with a structured implementation tracker covering responsibilities, priorities, deadlines, dependencies, progress and evidence of completion.
The complete Action Plan is included with your Preclinical QMS Package.
DEVELOP ALONGSIDE YOUR PRODUCT
Start simple & scale when you need it.
The transition from preclinical development to the first clinical trial is one of the most important quality milestones in drug development. The goal is not to create unnecessary complexity. It is to establish a QMS that reflects your actual responsibilities as a clinical trial sponsor.
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.
PAPER TO DIGITAL QMS
Use your existing eQMS or let us help you choose one.
The OZQA Phase I/II QMS is system independent. You are not required to purchase a specific software platform to use our documentation. The QMS can be implemented within an appropriate existing system or eQMS. If you are moving from a simpler preclinical setup into a dedicated electronic QMS, OZQA can also help define your requirements and assess suitable solutions. The system should support your quality processes and regulatory responsibilities – not dictate them.
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 clinical development often raises practical questions. How much QMS do you actually need? Which SOPs should be implemented first? Do you need an electronic QMS?
The right answer depends on your development stage, organisation, outsourced activities and regulatory roadmap. A clinical QMS should therefore be proportionate to the activities you perform today, while providing a foundation that can grow with your organisation.