Expert Pharmacovigilance Consulting
- Auditing
- Inspection Readiness
- Quality Management Systems
- Risk Management
- Training
Expert Pharmacovigilance Consulting
- Auditing
- Inspection Readiness
- Quality Management Systems
- Risk Management
- Training
We specialise in supporting pharmaceutical and biotechnology companies with Pharmacovigilance (PV) Quality, Risk Management and Regulatory Compliance. Our expertise resides in drug safety, and we are here to provide customised solutions tailored to your specific needs. Browse our services and get in touch to learn more about how we can help your company.
At SMPV Limited, we provide pharmacovigilance quality support to enhance companies regulatory compliance.
In addition to the conduct of Good Pharmacovigilance Practices (GVP) audits and inspection readiness activities, we help clients with the development of robust quality management systems, strategic audit planning, change management and risk-based assessment and prioritisation to elevate your pharmacovigilance system.
Companies need to constantly adapt and maintain regulatory compliance in an ever-changing environment from new regulations to new technologies.
Limited resources, more activities.
At SMPV Limited, we understand those challenges and the potential constraints due to lack of internal expertise and limited resources.
We are here to support you and help optimising your company pharmacovigilance system and operations to achieve its quality objectives.
Let us help you take your Pharmacovigilance and associated Quality Management Systems to the next level.
Do you feel that your company lack internal expertise when it comes to GVP requirements?
Too many audits but not enough auditors?
Lack of process optimisation?
Is your organisation facing changes impacting your PV system?
Let us support you maintain regulatory compliance with our expertise.
We can assist with the conduct of audits and associated auditing activities. Our expertise ensures the identification of gaps to support the improvement of your systems and maintenance of compliance.
Are you expecting or were informed of an upcoming inspection? We are here to assist you throughout the process. We participated in numerous inspections and supported companies from preparation to closure.
Whether you are about to license your first product, change database, outsource new activities, we can help you manage those changes and ensure your processes and systems are adapted to maintain regulatory compliance.
We specialise in providing practical and tailored solutions to help you optimising your company pharmacovigilance system and operations to achieve your quality objectives. We work with you to identify areas of improvement, streamline processes, and help you run your activities more effectively.
At SMPV Limited, we are passionate about helping companies maintaining compliance with pharmacovigilance requirements.
We understand the challenges faced by your company. From lack of internal expertise or resources, when it comes to quality, we are here to help.
We have over 25 years of experience in the industry, including almost 15 years in quality, conducted over 150 audits worldwide and supported numerous Good Pharmacovigilance Practices (GVP/GPvP) and Good Clinical Practices (GCP) inspections.
We have a track record of delivering our projects on time and consultancy work that add value increase efficiency, ensure compliance and improve quality.
We work closely with our clients to understand their unique needs and develop strategies and solutions that are tailored to their specific goals.
Contact us today to schedule a consultation and discover how we can help your company and take your pharmacovigilance system to the next level.
“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
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