Post-authorisation
Managing the benefit-risk balance through the lifecycle of a product is as important as getting it through the initial approval and submission phases. Whether authorisation is pursued via the adaptive licensing route or the more conventional lifecycle management pathways, on-going management is required to ensure your product remains compliant and commercially focused. Changes in scientific guidelines, updates to legislation, manufacturing changes and product information updates often lead to variations being required. In addition, the renewal of marketing authorisations, application for line extensions or licence transfers as well as reclassification of medicines may need to be considered.
How can we help?
Our experienced consultants will support you through the whole array of post-authorisation requirements, including manufacturing changes, new market introductions, variations, renewals, line extensions and post-approval measures. We are able to help you navigate through this process, providing you with the necessary guidance, from completion of appropriate documentation to advice on the development of your post-authorisation strategy.
For a more detailed discussion on how we can help you, contact us on +91 886000 9879 or email us via our contact form
