QA/RA collaboration
Provision of quality assurance and regulatory affairs support through structured collaboration models, including consulting arrangements and long-term partnerships aligned with defined regulatory and quality objectives.
QA/RA & COMMERCIAL PARTNERSHIPS
Unipharma collaborates with manufacturers, CMOs and supply partners through structured QA/RA and commercial partnership models that support regulated access and supply activities. These collaborations are designed to complement internal capabilities while ensuring alignment with applicable regulatory requirements and quality standards.
Partnerships are defined through clear scopes, documented responsibilities and agreed governance frameworks, enabling compliant execution across complex and multi-party supply environments.
Strategic supply partnerships
Development of structured commercial partnerships to support access programmes, speciality supply and international distribution activities under defined quality and governance frameworks.
Integrated development models
Participation in collaborative models supporting clinical development, comparator supply or market preparation activities, where shared responsibilities and quality oversight are required.
Governed partnership execution
All QA/RA and commercial partnerships are managed through defined governance and quality frameworks covering regulatory compliance, operational oversight and risk management. Responsibilities are clearly allocated, and activities are monitored to ensure alignment with agreed objectives and applicable requirements.
This structured approach allows Unipharma and its partners to collaborate effectively across access, development and supply initiatives, while maintaining transparency, control and regulatory integrity throughout the partnership lifecycle.