Regulatory Affairs
At Eden Biodesign, we know that a strong regulatory package is essential to allow the commercial and clinical benefits of a new biopharmaceutical to be realised.
Our extensive capability has been gained through our own experience in developing biological medicines that have been successfully approved, combined with over a decade of providing expert global regulatory consultancy services. Building on this experience, our team of experts guide projects over the various regulatory hurdles encountered throughout product development.
Eden Biodesign’s dedicated Biologics CMC Regulatory and Technical Strategy Team are experts in a wide range of biosimilar and innovative biologic products including cytokines, growth factors, hormones, monoclonal antibodies, thrombolytics and vaccines.
Our activities within Product Chemistry, Manufacture and Analytical Control (CMC) and Regulatory Affairs include:
- Development of regulatory strategies for successful submission and approval
- Review and evaluation of data for licence application
- Dossier compilation (ICH M4Q) for clinical trials and market authorisation
- Organisation and support at meetings with regulatory authorities
- Compilation of scientific advice packages
- Organisation and compilation of response packages
- Specialist scientific advice and support in the areas of statistical evaluation, bioassay, virology, analytical characterisation, production strategy, method development and validation
- Involvement in development and approval of biosimilars policy
