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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.
Having written and experienced many successful biologic clinical trials and product licence applications, you can trust our team of consultants to be able to guide you over the various regulatory hurdles.
By combining our expertise with that of our specialist Biologics Regulatory Services group, we can offer expert advice on a wide range of biologics 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
