Exploring Common Questions for Your EU Drug Product Launch
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.
Almac Pharma Services provide a wide range of customised commercial services from supporting product launch, manufacturing and / or packaging drug product, to securing supply chain with global serialisation solutions.
Our flexible, quality-led commercial solutions range from orphan drug launches to ongoing high-volume commercial product manufacture, packaging and supply.