Integrating AI Governance, Quality and PV into Your Strategic Advantage
We unite compliance, quality and AI governance with technology and expertise. We build resilient solutions, ensure strong oversight, and enable your sustainable growth.
Since 2008, NostraPharma has combined PV proficiency, quality and audit expertise with AI governance, helping pharma and biotech companies safeguard patients, develop regulatory compliance agility while embracing technology and innovation with the confidence. We have a strong collaboration and partnerships within the industry, academia and many associations. With a worldwide network and offices in the UK, Bosnia, and Czech Republic, our clients are supported across various territories and regulatory frameworks.
Our Services
AI/ML Services
- AI Governance
- AI Compliance Officer
- AI Risk Management Frameworks
- Risk & Impact Assessments/Gap Analysis
- Design & Implementation of AI Policy
- Socio-technical/Bias Testing
- Independent AI/Algorithm Audits
- AI Training, Mentoring & Coaching
Quality & Auditing
- Quality Consultancy
- GVP, GCP and CSV Auditing
- Independent Audits of QA groups
- Inspection/Mock Inspection Support
- Risk-based Audit Planning
- QMS Set-up, Solutions and Maintenance Support
- ISO Certification Support
- ISO Lead Implementer & Quality Audits
- Auditors Training, Mentoring & Coaching
Pharmacovigilance Services
- PV Strategic Consultancy
- QPPV Office Support
- PV System Gap Analysis
- PV System Set-up & Improvements
- PV Resourcing
- PV Training, Mentoring & Coaching
- Inspection and Post-inspection Support
- PV QA Support
- Prequalification & Audits of PV AI Solutions
Why NostraPharma?
Integrity - Certified & Independent
Independently certified AI/ML and ISO auditors and trainers bringing trust to every engagement.
Decades of Collective Knowledge
Over 1,700+ years of combined experience in PV, quality, training and AI bringing unmatched depth and perspective to every project and every role.
Reliability
Our auditors conducted between 100–300 audits each.
Proven Global Expertise & Perspective
Experience supporting the many regulatory inspections including FDA, MHRA, EMA, and leading EU regulatory authorities.
Partnership – Scalable, Sustainable Support
Flexible model for a long-term support and scalability.
Trusted in the industry, and associations
In the business since 2008, with a proven record of undertaking complex projects and audits.
Collaboration and strong partnerships across academia, industry and beyond
