Regulatory Lifecycle Management
Regulatory Knowledge Can Expand a Market.
Regulatory Intelligence Can Unlock the World.
By staying up-to-date on the ever-changing regulatory landscape, you look into the future. You are prepared to take the right actions at the right time. Reliable regulatory expertise saves you time and resources, as even small regulatory issues may grow into big problems if not handled properly.
Taking a regulatory project lead role for a product or a portfolio in the international market means leading and coordinating numerous projects, such as NDAs, variations, line-extensions, MAH-transfers, and PIP-procedures. Furthermore, you are the established global contact point for the local markets. Our consultants have extensive experience in managing product portfolios and leading regulatory projects in the global market, from the US, to Europe, to Asia – and in all stages through development and maintenance. We collaborate with both big pharma and small companies with the same dedication and accuracy, and we offer both operational and strategic project management.
European Registration Specialists
We also assist with specific services for European registration dossiers and we support all European registration procedures. We manage the lifecycle of your product and make sure you can maintain it on the market. Our foresight and knowledge of the ever-changing pharmaceutical landscape will ensure you stay one step ahead.