MAH QMS Package
Becoming a Marketing Authorisation Holder changes your responsibilities. Whether you are acquiring the rights to an existing medicinal product, licensing a product for the European market or establishing a European commercial organisation around a product developed elsewhere, you need a Quality Management System that reflects your responsibilities as MAH.
QMS FOR MARKETING AUTHORISATION HOLDERS
The OZQA MAH QMS Package is designed for pharmaceutical companies taking responsibility for an authorised medicinal product without an established MAH quality system. Start with a complete, ready made quality framework and choose whether to customise and implement it internally or with support from OZQA’s quality experts.
Build a QMS on your own or with our help.
COMPLETE
MAH
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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 MAH QMS with an audit-ready documentation package.
Ideal for
Organisations becoming an MAH with experienced internal Quality resources available to customise and implement the QMS.
Package Includes
38 pre-written SOP's
24 ready to use log forms
COMPLETE
MAH
___
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
Organisations that need a complete MAH QMS and support adapting it to their products, organisation and outsourced operations.
Package Includes
38 pre-written SOP's
24 ready to use log forms
Customisation
Implementation
5 h. training
14 days support
THE MAH QMS MODULES
A QMS designed around your responsibilities as MAH.
The MAH QMS Package provides the Quality framework for organisations taking responsibility for authorised medicinal products. It is particularly relevant when acquiring or licensing an existing product, establishing a European MAH organisation or taking over responsibility for a product developed by another company. The QMS is structured around the responsibilities retained by the MAH while allowing manufacturing, testing, storage and other activities to be performed by qualified external partners.
OPERATE THROUGH QUALIFIED PARTNERS
Maintain control of outsourced Quality activities.
Many MAHs operate through external manufacturers, laboratories, QPs, warehouses, distributors and specialist service providers. Outsourcing these activities does not remove the need for a structured Quality system. Your organisation needs clear responsibilities, documented interfaces and appropriate oversight of the partners performing activities on your behalf.
Documents included in the complete package
Your MAH Quality system should support:
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Clear Quality roles and responsibilities
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Controlled documentation and records
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Qualification and oversight of GxP partners
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Quality Agreements
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Deviations and CAPA
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Change Control
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Quality Risk Management
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Product complaints and recalls
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Audits and self inspection
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Quality metrics and Management Review
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Oversight of manufacturing and product release interfaces
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Traceability of important Quality decisions
OZQA can also support implementation, partner qualification, Quality Agreements, audits and ongoing Quality oversight.
ALREADY HAVE A CORE QMS?
Add documentation to your existing QMS.
If you already have a quality foundation in place OZQA provides pre-made QMS packages including all SOPs and forms needed to stay compliant as a sponsor for late stage clinical trials. Choose to update your QMS with your own internal QA personnel or get hands on support from our expert consultants.
ALREADY HAVE A CORE QMS?
ADDITIONS
MAH
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UPDATE QMS
YOURSELF
Update your current QMS yourself. Add the processes required to evolve your existing quality system into a MAH QMS. With 98% pre-written GxP compliant documents.
Ideal for
Companies with established core quality processes and internal QA resources to implement the documents.
Package Includes
Pre-written SOP's
Ready to use log forms
ADDITIONS
MAH
___
UPDATE QMS
WITH SUPPORT
Already have a foundational QMS but don't have the resources to implement the documents yourself? Let's help you all the way to GxP compliance.
Ideal for
Companies with established quality system but limited QA resources. We help you all the way to an active QMS!
Package Includes
Pre-written SOP's
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
Pharmaceuticals
If pharmacovigilance activities are managed in house, OZQA provides a dedicated In house Pharmacovigilance QMS Package. If your organisation distributes medicinal products while outsourcing physical warehousing, the MAH framework can be expanded with the GDP Distribution Package.
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 MAH 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 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 your 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.