In the last years, ASPHALION had the opportunity to gather comprehensive expertise working in Biosimilar projects. These projects included strategic advice, feasibility assessment, as well as the preparation of entire CTD files for submission to the European Medicines Agency (EMA).
The value of well-planed and carefully executed regulatory activities has become evident in all of these projects. Our consultants have now prepared a White Paper that summarizes some of the experience that they have acquired.
We are proud to present “Biosimilars – What are the critical regulatory milestones during development and registration?”, which also provides a general introduction to Biosimilars as well as a summary of new and existing regulations.
Please feel free to contact us at [email protected] if you have questions or would like to receive further information.
