Managing global release in a changing regulatory environment

An analytical testing perspective Whether you are using an insourcing or outsourcing strategy and working with a CMO or CRO, biotechs and pharmaceutical companies are all pointing toward the same goal: rapidly achieving commercialization of their therapy. However, there are multiple approaches in early phase development that can greatly affect …

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How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies

How could a no-deal Brexit affect my medical device lifecycle? Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario. The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical …