Vast amounts of time, effort and budget is dedicated to getting a product approved through regulatory agencies, but a wider challenge can then be encountered in getting it to market, and then keeping it there. Post authorisation commitments are a big undertaking for pharma and biotech companies and critical to ensuring the future survival of the product and for the business.
NDA has a dedicated team of post authorization experts, experienced in EU product launches, pharmacovigilance, line extensions, renewals and inspection-related commitments. The team have worked within the key agencies in Europe and within industry, providing an all-round view of what’s required and how to make it happen.
Our track record
NDA has worked with a large number of clients assisting with their post authorization needs from big pharma and biotech companies to small start up companies.
How we help
NDA is optimally placed to provide support for all key aspects of your post authorization requirements. From a new product launch, line extension, pharmacovigilance needs or compliance with paediatric regulation as well as offering full regulatory support with product life-cycle maintenance.