Compliance and Quality Assurance
Confidence built on compliance, our QA and documentation teams help you meet every standard with precision, transparency, and trust.
Regulatory compliance isn’t just a box-ticking exercise, it’s the foundation of patient safety and market credibility.
At Novarion Pharma Services, we deliver tailored quality and compliance support designed to simplify complex processes, reduce risk and ensure full alignment with global regulatory expectations.
We help clients navigate the requirements of MHRA, EMA, FDA, and ICH guidelines with a clear, structured approach. Whether you’re preparing for an inspection, building a validation plan, or enhancing your quality systems, our team acts as an extension of yours, ensuring consistency, accuracy, and readiness.
Our Key Capabilities
Quality Management Systems (QMS)
Implementation and optimisation of QMS frameworks tailored to your organisation’s scale and regulatory landscape, including CAPA, deviation control and change management processes.
Documentation and Audit Readiness
End-to-end documentation support: SOP development, validation protocols, and audit trail management. We prepare you for both internal and external inspections with full traceability and evidence-backed compliance.
Validation and Qualification
Equipment, facility, and process validation performed to GMP standards, ensuring reproducibility and regulatory confidence from start to finish.
Regulatory Submissions and Technical Writing
Preparation and review of technical files, quality summaries and CMC documentation aligned with current regulatory guidance.
Continuous Improvement
Our QA specialists work collaboratively to identify efficiencies and improve ongoing compliance performance, embedding a culture of quality across your organisation.
Explore our other key services
Novarion have been instrumental in helping us scale our API production with full regulatory oversight.
Director, European Biotech
Novarion have been instrumental in helping us scale our API production with full regulatory oversight.
Director, European Biotech
Novarion have been instrumental in helping us scale our API production with full regulatory oversight.
Director, European Biotech
Novarion have been instrumental in helping us scale our API production with full regulatory oversight.
Director, European Biotech
Novarion have been instrumental in helping us scale our API production with full regulatory oversight.
Director, European Biotech
Novarion have been instrumental in helping us scale our API production with full regulatory oversight.
Director, European Biotech
Your Next Step in Pharmaceutical Excellence
Discover how Novarion’s integrated manufacturing, regulatory, and logistics expertise can accelerate your growth.