Business Need

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 Life Sciences Help?

Working with partners in both Europe and the US, Navitas Life Sciences 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 Life Sciences provides advisory services that balance speed – to – market, optimal market access and ultimate commercial success.

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Latest News

09
Jun2017

Life Sciences expert Navitas augments end-to-end capabilities

Navitas, a technology-led Life Sciences services provider across Clinical, Regulatory and Safety, announced that...

20
Apr2017

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and...

Navitas Life Sciences welcomes the opportunity to provide comments on this Reflection Paper... Navitas Life...