GVP Quality consulting services for the pharmaceutical industry
- Auditing
- Inspection Readiness
- Quality Systems
- Process improvements
- Training
At SMPV Limited, we support pharmaceutical and biotechnology companies through the conduct of quality activities specific to pharmacovigilance.
In addition to GVP audits and inspection readiness activities, we support clients with quality management and pharmacovigilance systems development and associated process improvements.
Companies need to constantly adapt and maintain compliance with pharmacovigilance regulatory requirements in an ever changing environment from new regulations to 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 system and associated quality processes to the next level.
Do you feel that your company lack internal quality expertise when it comes to GVP requirements?
Do you feel that you have too many audits but not enough auditors?
Is your organisation facing changes impacting your PV system?
Let us support your quality activities and processes to maintain 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 pharmacovigilance system, outsource activities, we can help you managing those changes and ensuring your processes and systems are adapted to maintain compliance with relevant regulatory requirements.
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 you.
We have over 20 years' experience in the industry, including 10 years in quality, and conducted over 100 audits worldwide and supported numerous GVP & GCP inspections.
We have a track record of delivering our projects on time and consultancy work that 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
Copyright © 2021 SMPV Limited - All Rights Reserved.
SMPV LIMITED is a limited company registered in England and Wales.
Registered number: 11388233
Registered office: 241 Mitcham Road, Tooting, London, England, SW17 9JQ
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