Drug development and drug approval are complex, expensive, and time-consuming involving multiple stakeholders such as drug developers, regulatory and health technology assessment agencies, and finally patients.

Due to the time-consuming nature of drug development the stakeholders involved are confronted with an evidence–time dilemma, i.e., either provide earlier access to new treatments based on preliminary evidence associated with a higher level of uncertainty, especially to those patients with a high unmet medical need, or generating a complete data package associated with less uncertainty, however, resulting in a later approval and thus a later access for patients.

We accompany your project navigating you through the development and approval maze and helping you to find the most appropriate regulatory strategy and path to approval. We assist you in choosing the appropriate and best regulatory procedure for your product and your organisation based upon a detailed analysis on pros and cons of the different procedures such as the centralised, decentralised, mutual recognition, and national application procedure.

Based on our clinical experience combined with our regulatory expertise we offer tailor made strategies for your product and independent due diligence services.

We analyse your projects and help you to fully understand the regulatory environment while considering precedents within the current regulatory landscape. We develop individual regulatory pathways for your projects together with your project teams.

We foster optimal strategies to generate clinical evidence for a particular indication and provide guidance on specific aspects of clinical development, regarding target population, adequate clinical endpoints, or entire protocol designs, if needed.

We also provide strategic advice on regulatory requirements regarding quality and non-clinical aspects. Finally, we support you to effectively compile your eCTD which complies with the ICH guidelines and regional specifications.