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Phase I/II Additions QMS Package
Phase I/II Additions QMS Package
Phase I/II Additions QMS Package

Phase I/II Additions QMS Package

€6,995.00Price
Excluding VAT
Expand your existing QMS for clinical development.
 
Moving into clinical trials introduces new responsibilities, risks and regulatory expectations.
 
The OZQA Phase I/II Additions QMS Package is designed for biotech and pharmaceutical companies that already have the OZQA Preclinical Core QMS, or an equivalent quality foundation, and need to expand their QMS to support Phase I and Phase II clinical development.
 
Instead of replacing your existing system, the package adds the quality processes that become increasingly important when your organisation takes on clinical sponsor responsibilities.
 
Every document in the package is professionally written, pre-filled, and 90–99% complete, requiring only minimal customization such as your company name and QA approver.

They are aligned with GxP, ICH, EMA, and FDA expectations and developed by QA experts with real inspection experience.
 
This additions QMS package allows startup and early-phase biotech organizations to build a compliant, scalable and inspection-ready quality system within days instead of months without relying on expensive consulting hours.
 
All documents are editable Word files, ready for integration into your QMS or electronic QMS platform.
 
The Phase I/II Additions package includes 8 fully written SOPs and 6 log forms :
 
Quality Manual
An updated Quality Manual reflecting the expanded scope, responsibilities and quality processes associated with clinical development.
 
Recall SOP
Defines how potential all investigational medicinal products (IMP) recalls are assessed, coordinated, documented and escalated when required.
 
Product Complaints SOP
Establishes a controlled process for receiving, assessing, investigating and documenting IMP product quality complaints.
 
Safety Reporting SOP
Defines responsibilities and processes for safety information and reporting during clinical development, including oversight of relevant outsourced activities.
 
Monitoring New Regulations SOP
Establishes a systematic approach for identifying, assessing and implementing relevant changes to regulations, guidelines and regulatory expectations.
 
Change Control SOP
Provides a structured process for assessing, approving, implementing and documenting changes that may affect quality, compliance or clinical activities.
 
CAPA SOP
Defines how quality issues are investigated and how corrective and preventive actions are identified, implemented, followed up and documented.
 
Serious Breach SOP
Establishes the process for identifying, assessing, escalating and reporting potential serious breaches related to clinical trials.

  • What’s included

    ✓ 8 fully written SOPs
    ✓ 6 template log forms


    ✓ Phase I/II clinical quality processes
    ✓ Designed to complement an existing Core QMS
    ✓ Editable documents
    ✓ Ready for company specific customisation
    ✓ Expandable with Phase III QMS processes

  • Suitable companies

    It is therefore particularly suitable if you:

    • Already use the OZQA Preclinical Core QMS
    • Have an existing QMS covering the fundamental quality processes
    • Are preparing for your first clinical trial
    • Are transitioning from preclinical development into Phase I
    • Need to strengthen sponsor oversight and clinical quality governance

  • Benefits

    Benefits

    • Save 3–6 months of documentation work

    • Achieve inspection readiness rapidly

    • Avoid costly consultant hours

    • Ensure consistent, GxP-aligned documentation

    • Build investor confidence with a robust QMS

    • Scale smoothly into Phase III and commercialization

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