How INITS Can Support You to derisk your development program through regulatory consultations

At INITS, we specialize in guiding biotech companies through the scientific advice process from strategy to execution.

INITS can assist in identifying the most appropriate meeting.

Our expert team can support you with:

• Preparing a clear, compelling briefing book

• Organizing timelines and coordinating internal alignment

• Attending meetings with agencies and helping interpret feedback

• Advising on how to incorporate advice into your development plans

Scientific advice can be complex, but you don’t have to navigate it alone.

At INITS, we were involved in multiple scientific advice:

• Scientific advice with EMA

• Simultaneous National Scientific Advice (SNSA)

• Guichet Innovation et Orientation (GIO) in France

• Pre-IND meeting (FDA)

A comparison between the different meetings is provided below:

Final Thought

Scientific advice doesn’t just help you meet regulatory requirements, it empowers you to move forward with confidence. A well-prepared consultation is a hallmark of a mature development strategy, signaling both scientific rigor and regulatory awareness.

If you're navigating early or late-stage development, now is the time to consider how scientific advice fits into your roadmap.

Why Scientific Advice Is a Strategic Imperative in Drug Development

In the complex and highly regulated world of drug development, uncertainty can be costly both in time and resources. One of the most effective ways to reduce this uncertainty is through scientific advice from regulatory agencies.

Although voluntary, scientific advice is highly recommended at multiple stages of development: from preclinical to clinical phases, through to the submission of the marketing authorization application (MAA). And when used strategically, it can significantly enhance the quality and regulatory readiness of your product development strategy.

What Is Scientific Advice?

Scientific advice is a formal consultation with regulatory authorities (such as the EMA, FDA, or national competent authorities) to discuss the scientific and regulatory aspects of a medicine’s development. It’s not a guarantee of approval but it’s a strong foundation to build upon.

Depending on the stage of development, scientific advice can guide both quality (CMC) strategies and the design of non-clinical and clinical studies to ensure regulatory alignment.

Why Is It So Valuable?

Scientific advice is a valuable tool to de-risk development, save time and costs, build external credibility, and support strong regulatory submissions. It’s also a great opportunity for internal alignment by formalizing your development thinking and surfacing key decisions.

Don't forget: planning is crucial. These meetings typically require at least 3 months of preparation, and thoughtful coordination across teams.

By Rosa KHELIFA, CMC & Regulatory Consultant at INITS