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Agency Interactions.

Good communication is important.

Communication with competent authorities is very important at any stage of your product’s lifecycle, whether your strategy for submission still needs to be prepared, or submission has already taken place and your dossier is under evaluation.

We have both the local communication networks and the global communications experience required to work with authorities worldwide. We can lead communication on your behalf, exchange high level opinion with authority experts, identify and discuss potential risks and  propose alternative options to successfully reach mutually acceptable solutions.

We also monitor regulators’ initiatives to develop new communication channels with stakeholders for harmonized decisions, focusing on scientific development and relevant regulatory frameworks, especially for innovative products or therapeutic concepts.

Regardless of whether you’re an innovative drug developer who wants to optimize your development program early, or you need to redesign an already marketed product, the earlier you contact us the easier it will be to create faster, better, smarter communications solutions.