Compliance is required beyond the attainment of marketing authorisations
ICON is active in a wide variety of post-licensing activities pivotal during the product lifecycle.
We are familiar with the many lifecycle challenges that our customers face in the market place. Our insight and achievements in this field ensure your post-licensing opportunities are maximised.
We support you in maximising your product’s potential against patent erosion and competition by helping you implement lifecycle strategies, including line extensions to your original marketing authorisation. We can also help you face continuous compliance challenges, by providing strategic input and operational support into variation applications across the full spectrum of the EU CTD, renewal applications, annual safety reports, PSUR authoring and submissions management, as well as transfer of ownership applications and readability assessments.