Regulatory Affairs

Guiding your drug development program to reach the end you have in mind

A Roadmap for Success

From your first-in-human trial through your product's entire lifecycle, we work with you to leverage the full potential of the regulatory system. Our experts ensure the swift execution of applications and provide timely, strategic responses to regulator inquiries and concerns. We offer an objective perspective and act as a center of excellence for your operational regulatory activities, complementing your existing partnerships.

Regulator Engagement Is Key

The most effective way forward is often through direct engagement with regulators. Formal mechanisms like scientific advice and accelerated pathways provide opportunities to discuss, debate, and negotiate the science behind your product. Even in day-to-day activities, the right interactions with key regulatory representatives can drive progress and overcome setbacks. Our team has facilitated numerous meetings between companies and regulators, achieving optimal outcomes for both parties.

Your Data, Your Story

The regulatory dossier is more than a data binder - it's the full body of evidence and your case for approval. While the right data is essential, drawing appropriate conclusions and presenting a compelling, understandable narrative is equally critical. We excel at managing this process in dialogue with regulators, CROs, and your team.

We're With You All The Way

The marketing authorization is a crucial milestone, but it's not the end. Regulatory management of a commercial product is its own specialty. From launch through variations and potential withdrawal, we handle your US and European market activities. Let us take the regulatory burden off your shoulders so you can focus on delivering your product's full potential to the patients who need it.

Contact us to learn how our regulatory affairs experts can guide you safely and efficiently through the complex regulatory environment, ensuring the best path to approval and beyond.

Regulator Engagement Is Key

The most effective way forward is often through direct engagement with regulators. Formal mechanisms like scientific advice and accelerated pathways provide opportunities to discuss, debate, and negotiate the science behind your product. Even in day-to-day activities, the right interactions with key regulatory representatives can drive progress and overcome setbacks. Our team has facilitated numerous meetings between companies and regulators, achieving optimal outcomes for both parties.

Your Data, Your Story

The regulatory dossier is more than a data binder - it's the full body of evidence and your case for approval. While the right data is essential, drawing appropriate conclusions and presenting a compelling, understandable narrative is equally critical. We excel at managing this process in dialogue with regulators, CROs, and your team.

SERVICE LEADERSHIP

Laurie Smaldone Alsup

SVP Regulatory Science

Laurie Smaldone Alsup

SVP Regulatory Science

Laurie Smaldone Alsup

SVP Regulatory Science

OUR INSIGHTS

At SSI Strategy our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. It captures the state of the art of our industry today.

LET’S TALK

You don't have to go it alone!

Our experienced team has been there before, and we're ready to guide you through the unknown. Share your challenges with us, and together, we'll create a plan to efficiently reach your milestones and turn your vision into reality.

Let’s Bring Medicines to the World.

This field is for validation purposes and should be left unchanged.