Pharmacovigilance & Medical Information
Compliance with the legal requirement to have a comprehensive global pharmacovigilance system is mandatory not just for peace of mind and to avoid significant penalties if inspected, but also to sensitively assess the safety of your product when it undergoes development and emerges into the market. Our motto is “Protect the Product, Protect the Company”.
MWB Consulting is renowned for its expertise in global pharmacovigilance and offers a range of consulting services directly and a turn-key pharmacovigilance operation via its sister company, Medanta Pharmacovigilance Services Limited. Our services cover pharmacovigilance and device vigilance in both the pre- and post-marketing settings.
These services include:
• Provision of the Responsible Person for Eudravigilance
• Provision of the EU Qualified Person for Pharmacovigilance and deputy,
including comprehensive 24-hour availability
• Design, implementation and provision of global pharmacovigilance systems
• SOP writing
• Preparation of the EU Risk Management Plan, FDA RiskMAP
• Design and implementation of risk minimisation activities e.g. patient registry
• Audit of pharmacovigilance service providers and systems
• Pre-inspection audits and preparation for Agency pharmacovigilance
• Preparation of PSUR, PADER, ASR, AR
We have been asked many times by smaller biopharmaceutical companies to recommend a provider of medical information services, especially when the cost and effort involved in setting up a multilingual 24-hour service is beyond the remit of these companies. Spotting a gap in the provision of such a service, we are in the process of setting up our own medical information operations, which will be available to international clients wishing to market their products in Europe. We will offer a call centre, medical information professionals, and comprehensive enquiry management software and processes. We aim to integrate this service with our pharmacovigilance operations and provide a seamless post-marketing medical affairs function to our clients.
If you are interested in this service please contact us for more information or come back to our web site for future updates.