Understanding and managing the quality and potential risks of existing and new pharmaceutical products has never been more important than it is today. Ensuring this is done in an efficient and cost effective way, supported by the right expertise, process and systems, is critical to the survival of a drug on the market. The introduction of the new Pharmacovigilance Legislation in 2012 has made this even more paramount forcing greater focus on risk management and monitoring.
NDA has indepth expertise and experience of pharmacovigilance (PV) and managing risk for products already out on the market. We understand how a new drug needs to be tracked and monitored throughout its life, the data you now need to gather and store, the measurement and checks that will be undertaken to ensure its safety, and then how to deal with any potential concerns that may arise.
We understand the importance of incorporating PV considerations from early on in development. We can also give you a totally global viewpoint. We’ve worked with clients in Europe, the USA and Asia, advising and helping with any PV need when operating in Europe, becoming a true extension to the client’s team.
How NDA can assist you
NDA offers a complete portfolio of Pharmacovigilance and Risk Management Services that span the entire lifecycle of a product. NDA can provide critical reviews of your submission strategy, documents, and auditing of key processes, assist with strategic input and hands-on support to the questions raised by agencies, and help ensure that your organisation, processes and systems are ready for Agency inspections. We offer a full range of PV quality management services.
For established products, there are many new requirements that need to be in place by July 2015. This includes having a system in place to store safety feedback to make it easier to spot potential signals. NDA can assist in this process, putting in place a full monitoring and data collection process, from adverse reaction to signal detection and analysis. We can also provide you with an experienced Qualified Person (QPPV) or deputy or other support services as required. Plus, we can assist in authoring key documents (such as PSURs/PBRER, DSURs, RMPs), and design or rework critical quality processes so you can be rest assured you are compliant with the regulatory requirements.