The package is designed for pharmaceutical companies becoming or preparing to become a Marketing Authorisation Holder and needing to establish the Quality framework behind that role.For example, your organisation may acquire an existing medicinal product, license a product developed by another company or establish a European organisation to commercialise a product developed outside Europe.For centrally authorised products, the MAH must be established in the EEA.

Yes, this is actually one of the primary scenarios the package is designed for.A company may acquire or license the rights to an existing medicinal product without having operated the QMS used during its original development. The new MAH therefore needs a Quality system reflecting its own organisation, responsibilities, products and outsourced operating model.

Yes. An MAH does not need to manufacture the medicinal product itself.Manufacturing, testing and other activities may be performed by external organisations, but the MAH retains responsibilities associated with its role. EMA specifically notes that MAH responsibilities include areas such as outsourcing and technical agreements, and that delegating activities does not transfer the underlying MAH responsibilities.

The MAH package provides the core pharmaceutical Quality framework, but it does not replace a complete pharmacovigilance system.If your organisation intends to operate pharmacovigilance internally, OZQA offers a separate In house Pharmacovigilance QMS Package that can be connected to the MAH QMS.

GDP is available as a separate module.If your organisation will also distribute medicinal products, the GDP Additions Package can be added to the MAH QMS. This creates a combined MAH + GDP QMS without unnecessarily duplicating the Quality processes already included in the MAH system.

External manufacturers, laboratories and other partners can perform many operational Quality activities, but appropriate responsibilities and interfaces need to be defined and controlled.EMA guidance emphasises both the MAH's responsibilities and the need for appropriate arrangements between the MAH, manufacturing authorisation holder and relevant manufacturing or testing parties.

Yes. The documentation can be implemented by your internal Quality team or combined with OZQA support for customisation, implementation, training, partner interfaces and ongoing Quality activities.

No. If you already have quality procedures in place, OZQA can review your existing documentation and identify which documents can be retained, updated or supplemented. There is usually little value in replacing a suitable existing process simply for the sake of standardisation. The objective is to create a coherent and appropriate QMS, not necessarily to replace every document with an OZQA template.

Yes, this can actually make a structured quality system particularly valuable.CROs, CDMOs, laboratories and consultants may operate under their own quality systems, but those systems control their organisations, not yours.Your company still needs appropriate processes for selecting and overseeing external providers, defining responsibilities, reviewing critical deliverables, managing risks and maintaining access to important development records.As development progresses into clinical trials, sponsor oversight becomes particularly important. ICH E6(R3) explicitly places responsibility on the sponsor for appropriate oversight of investigators and service providers.

No. OZQA is system independent. You can implement our QMS documentation within your existing document management or eQMS environment, provided the system is appropriate for its intended use and applicable regulatory requirements. If your organisation already uses a suitable platform, we can help structure the QMS around your existing setup.If you do not yet have a system, OZQA can help you assess your requirements and recommend suitable eQMS solutions based on factors such as company size, development stage, regulatory requirements, workflows, integrations and budget.We do not believe every company needs the same system.The technology should support your QMS – not dictate it.

There is no single eQMS that is right for every organisation.A small preclinical biotech may be well served by a controlled SharePoint setup, while a larger clinical stage organisation may benefit from a dedicated eQMS with integrated document control, training, change control, CAPA and audit trails. OZQA can help evaluate available solutions and determine which type of system is appropriate for your current and future needs. Our QMS templates are not tied to one specific software provider, allowing you to select or change your technology without rebuilding the underlying quality framework.

Yes.The OZQA Preclinical QMS can be purchased as a ready to adapt documentation package for organisations with sufficient internal quality expertise.The package includes the core SOPs and supporting log forms needed to establish the system.If you need assistance, implementation and training support can be added separately.This means you can choose between a primarily self managed implementation and a more supported QMS implementation.

Yes. You can adapt the QMS to your company’s size, stage, and way of working. OZQA’s approach is to customise only what is necessary, so you get a practical system that fits your operations without adding unnecessary cost or complexity.

Yes. All OZQA documents developed for pharmaceuticals are aligned with GxP, ICH, EMA, and FDA expectations for documentation and quality systems. They’re designed to pass audits and inspections without additional rewriting. All documentation is developed by QA professionals with real experience from biotech, clinical, and pharmaceutical companies.Our team has supported both early-phase and commercial-stage organizations through audits and regulatory submissions.

The implementation timeline depends on the size and complexity of the organisation, the number of existing processes and documents, the selected document management system and how much support is required.A small organisation starting with the OZQA Preclinical QMS can typically implement the system progressively rather than trying to introduce every process at once.OZQA can develop an implementation roadmap that prioritises the processes most relevant to your current activities and development milestones.