Building Better Biotechs

From Concept to Commercialization

More Than a Service Provider

We are your dedicated partner in turning groundbreaking ideas into tangible solutions that make a difference. 

Combining our therapeutic expertise with strategic problem-solving, we help you overcome obstacles and reach every milestone on your journey.

OUR SERVICES

Our multidisciplinary team combines deep expertise with strategic insight to provide the tailored support biotech companies need at every stage of development. As your reliable partner, we offer a comprehensive range of services to help you transform your innovative ideas into reality. 

Discover Our Podcast

Whether you're a seasoned executive or an aspiring leader, our podcast offers valuable perspectives and practical advice to support you at every stage of your product development journey. 

Strategic Thinking

Develop With The End In Mind

Pre-Clinical

Early Development

Late Development & Submission

Commercial Products

Pre-Clinical

Our team combines essential expertise to identify the best targets and ensure compliance with pre-clinical regulatory standards. We address toxicology concerns and chart the optimal course to First-in-Human (FIH) trials. 

Early Development

We transform assets and organizations into clinical-stage entities by establishing the necessary infrastructure and teams. This enables safe, successful early trials and lays a strong foundation for later development stages.

Late Development & Submission

Focusing on key evidence requirements for all stakeholders, we develop with the end goal in mind. Our approach drives organizational thinking and core capabilities to provide a robust evidence base for optimal regulatory approval, payer acceptance, and patient outcomes. 

Commercialization

Preparation for launch and post-market success begins years in advance. We leverage our diverse experiences to provide the data, evidence, and education needed to differentiate your asset’s value story and ensure successful market entry. 

NEWS

2023.08.08

NDA Group and SSI Strategy Join Forces

Today we are excited to announce the merger of NDA Group and SSI Strategy!
2023.02.08

Unmet Medical Need: A Regulatory Perspective

Join us on Wednesday 22nd March 2023 at 13:00 GMT| 14:00 CET | 09:00 EDT, when Jan Sjöberg will discuss the regulatory perspective of unmet medical need as a key criterion for drug development.

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.

Building Better Biotechs

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