It is only when a product reaches the market that it starts to generate value – for patients, doctors and the company behind it. Ensuring that the product is used appropriately and that it continues to be safe is a key challenge for any pharmaceutical company. Failure to do so may result in the product being withdrawn from the market with severe consequences for the company behind it and the patients who have put their trust in it.
NDA has a team of some of the foremost former EU regulators and industry experts that can guide you through all forms of pre and post authorization requirements, procedures and activities to ensure your product’s safety and quality is managed in an optimal way. Many of our experts are widely visible and internationally recognized for their thought leadership and contributions to many important committees in the space. Our expertise gives you peace of mind that your products are managed optimally to the right standard.
Our track record
NDA has supported companies of all types and sizes to ensure that processes are optimized and that safety outcomes are improved in an efficient manner. We have established top of the line quality management systems from scratch, as well as contributed to clients’ successfully recovering from serious deficiencies discovered in their quality management systems, both through internal findings and as unearthed by Agency inspectors. In addition we’ve successfully supported hundreds of clients performing a variety of tasks ranging from designing and authoring risk management plans to putting in place and manning the client’s QPPV role.
How we help
Our experts can support you to implement safety governance and quality management, create resourcing models and train key personnel, design process and advice on systems for collection and management of safety information from all sources, support your products risk management planning activities and design risk mitigation strategies. We also serve as QPPV for clients and support in the drafting of key documents and advice on critical processes such as signal management, continual benefit-risk assessment, planning and conduct of risk-based audits and audit programs, managing CAPA responses and preparing your team and system for pending Agency inspection and safety related hearings and face-to-face Agency interactions.