Expert Pharmacovigilance Consulting
- Audits
- Inspection Readiness
- Quality Management Systems
- Risk Management
- Training
Expert Pharmacovigilance Consulting
- Audits
- Inspection Readiness
- Quality Management Systems
- Risk Management
- Training
Empowering pharmaceutical and biotechnology companies with Pharmacovigilance (PV) Quality Systems, Risk Management and Regulatory Compliance.
Browse our services and get in touch to learn more about how we can help your company.
We specialise in pharmacovigilance, regulatory compliance, and quality systems consulting for the pharmaceutical and biotechnology industries. With decades of industry experience, we support clients worldwide in meeting GVP, GCP, ICH and beyond standards with precision and efficiency.
At SMPV Limited, we have proven expertise in global pharmacovigilance systems and understand the challenges faced by companies in an ever-changing environment and limited resources.
Limited resources, more requirements, more activities.
We provide end-to-end support and expertise to elevate your Pharmacovigilance and associated Quality Management Systems to the next level. We work closely with our clients to understand their unique needs, to develop strategies and solutions tailored to their specific goals.
We offer project-based collaboration.
With a track record of delivering our projects on time, we provide consultancy work that add value, increase efficiency, improve quality and support compliance with regulatory requirements.
We perform remote and onsite GVP audits and associated auditing activities. Our expertise ensures the identification of gaps to support the improvement of your systems and maintenance of compliance.
We have proven success supporting companies in numerous inspections (including MHRA, EMA, FDA) from preparation to closure.
Implementation and optimisation of your QMS for PV Compliance. We help you run and manage your activities more effectively and efficiently.
From inspection preparation to change management, we work with you to identify, monitor and mitigate risks.
Get on-demand knowledge where and when you need it. We provide in-depth training on best practices and quality management.
“I have had the pleasure of working with Stephanie as part of our PV inspection readiness activities. Stephanie’s ability to support the development of the framework for our PV inspection readiness program was instrumental in the successful outcome of the PV inspections which followed. Her extensive knowledge of the PV HA regulations and QMS are winning qualities any company would greatly benefit from.”
Head of PVQA Inspection Readiness, Pharma Company
“Very happy with the PV Audit services provided by Stephanie. A pleasure to work with.”
Head of R&D Quality and Risk Management, Pharma company
SMPV Limited
London, United Kingdom
We use strictly essential cookies. You may disable cookies, but please note that some parts of this website may become inaccessible or not function properly.