Early Development Interactions & Strategy For the EU.
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Summary.
Our client, a US based pharmaceutical company – Small and Medium-sized Enterprise (SME), had a small molecule product in the preclinical development phase. They were at the beginning of their interactions with the EMA and contacted us to assist them. They required a service provider located in the EU to serve as a bridge to the EMA, to support them in capitalizing on the incentives available to SME companies in Europe, and to provide them with consultancy on EU regulatory strategy.
The client requested support with the following:
EU Regulatory Strategy and advice for early development programs.
Initial interactions with the EMA.
Review of condition precedence in the EU and US for Orphan Drug Designation (ODD).
Challenges.
These are some of the challenges the client faced, which led them to contact Arriello:
Knowledge of EU legislation and EMA programs:
EU legislation is challenging, particularly given its dynamic and frequent updates. Compounding this complexity is the lack of harmonization with US legislation, which makes it particularly difficult for US-based professionals to understand the initial regulatory steps required in the EU and the various programs offered by the EMA.Therapeutic indication:
The client faced challenges in determining the most appropriate therapeutic indication for their product, and its influence on programs, such as PIP, ODD and PRIME, as well as their US regulatory strategy.Time zone issues:
As the client was based in the US, time zones hindered efficient communication with European authorities, highlighting the need for a European partner, with specific experience.Client’s limited resources:
The necessity of having the support of an expert team capable of managing the diverse challenges posed by EU legislation.
Solution.
Our experienced team delivered comprehensive regulatory advice that encompassed a variety of crucial activities:
Provided EU regulatory consultancy, offering guidance on the range of support and benefits available for SMEs, outlining the Early Development Programs offered by the EMA.
Developed a tailored EU Regulatory Strategy that considered the client’s product and stage of development, identifying challenges and opportunities inherent in the early development phases.
Facilitated initial EMA interactions, by providing guidance, communicating with the agency, organizing meetings and conducting rehearsal sessions.
Conducted a condition precedence review in both EU and US markets, with the Arriello team providing findings and strategic proposals for the most suitable Indication for ODD submission.
Regulatory pathways and strategy in EU & UK, including PIP, PRIME, ODD & ILAP.
Our Holistic Approach.
Arriello’s strategy involved the creation of a specialized team of regulatory experts, overseen by an experienced Project Manager. This approach established a single point of contact and a clear communication channel, thereby enhancing efficiency and facilitating seamless interactions, which effectively met the client’s expectations and timelines.
Our cross-functional team was able to adapt to the client’s needs and expectations to provide optimal advice aligned with the various programs offered by the EMA. Arriello’s regulatory team played a pivotal role in supporting the project, ensuring that they were well-prepared to navigate the complexities of the EU regulatory environment.
Need expert support with EMA strategy for your SME? Partner with Arriello today.
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