Understanding global demands from the perspective of regulators, patients, healthcare providers and payors is a critical necessity when creating a global regulatory strategy that will support the development and marketing of a drug product. Regulatory professionals face many challenges when defining a global regulatory strategy that includes multiple regulatory considerations in the major regions of the world where marketing applications are pursued as well as different application requirements.
How Can Navitas Help?
Working with partners in both Europe and the US, Navitas provides high quality, expert strategic regulatory advice throughout the lifecycle of client’s products. Ranging from regulatory requirements and strategy for early clinical studies to the optimal regulatory pathway to market for new products, generics and line extensions, Navitas provides advisory services that balance speed – to – market, optimal market access and ultimate commercial success.
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