How We Work
At SSI Strategy, we partner with biotech companies to navigate the complexities of bringing novel therapies to market.
Approach
Our unique approach integrates deep medical and business expertise to maximize therapeutic value at every stage from translational development to product launch. We engage with our clients in three key phases:
Build
We start with a strategic kick-off to gain alignment and plan an execution strategy. Our team creates a roadmap of key milestones and begins resourcing your team to tackle urgent projects.
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.
Transition
We understand your organization, so we're prepared to support your next emerging challenge. Whether it's due diligence on a new asset, new indication evaluation, BD partnering, or phasing out our team, we work closely with you to adapt to your changing needs.
Our proven methodologies and experienced team ensure you have the strategic guidance and hands-on support to meet critical milestones and deliver innovative therapies to patients in need. Partner with SSI Strategy to confidently navigate the unknown and maximize the potential of your asset.
Let's bring medicines to the world, because the world is waiting. Contact us to learn more about how we can support your unique needs.
Agile and skills Resources
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.
