Launching a drug product in the EU has many nuanced regulatory strategy considerations that a biopharmaceutical company must keep in mind while planning a launch. Proactively considering these procedures and adequately preparing for what will be needed prior to starting the process is crucial to ensure the most efficient and cost-effective process with minimum risk.
Brian Lavery, Regulatory Affairs Lead at Almac Pharma Services discusses the most common questions when launching your drug product with International Clinical Trials.