Regulatory Affairs

Regulatory Strategy: The foundation of successful drug development 

A Roadmap for Success

With over two decades at the forefront of drug development, our years of experience have taught us that investing in a robust regulatory strategy from the start of the drug development process is not just a wise choice – it's a necessity.

A well-designed regulatory strategy serves as the bedrock upon which all other aspects of drug development are built, ensuring that your product meets the stringent safety, efficacy, and quality standards set by regulatory authorities.

Develop with the End in Mind

A clear target product profile (TPP) is the cornerstone of a robust regulatory strategy. By defining your end goal upfront, you create a roadmap that guides decision-making, resource allocation, and risk management throughout the development process.

Aligning your efforts with the ultimate vision of commercialization significantly improves your chances of successfully bringing a new product to market. 

Agency Engagement is Key

Engaging with regulatory agencies early and often is key to a successful regulatory strategy. Our team's extensive experience in facilitating productive interactions with major regulatory bodies, such as the FDA, EMA, and MHRA, is the foundation of our regulatory strategy. We guide you through the complex requirements for approval, proactively communicating with regulators and addressing their concerns. This approach streamlines the approval process and minimizes setbacks, ensuring your product meets the necessary standards for success. 

Think Globally

A regulatory strategy that transcends borders is an essential component to guide your development journey. We specialize in crafting comprehensive, multi-jurisdictional dossiers that pave the way for swift approval across different regions. By proactively designing your dossier to meet the requirements of multiple regulatory agencies, you can avoid duplicating trials, minimize evidence generation, and conserve precious time and resources.

Our approach accelerates your product's entry into international markets, unlocking the door to global success. 

Agile Regulatory Support

We understand that your regulatory expertise needs fluctuate throughout the drug development cycle. Demand for regulatory support peaks during critical phases such as early development or regulatory submissions.

Our flexible, scaleable solutions allow us to seamlessly integrate into your team, providing the precise skills and expertise you need when you need them most. This adaptable approach grants you access to top-tier regulatory support without the commitment of full-time hires, ensuring efficient and effective resource allocation. 

Why Choose Us?

Our track record speaks for itself: we've contributed to the approval of more than a quarter of all new medicines in the US and EU over the last five years.

Our unique blend of strategic insight, hands-on experience, and agile support ensures we can navigate the most challenging regulatory hurdles and deliver results for clients of all sizes. With our deep understanding of the regulatory process and flexible, tailored approach, you can confidently achieve your product development goals faster and bring your innovative therapies to patients without unnecessary delay. 


Laurie Smaldone Alsup

SVP Regulatory Science

Kim Forbes McKean


Björn Carlsson

Director NDA Advisory Board


At SSI Strategy, we believe that knowledge is a key driver in building better biotechs. Our Insights provide valuable information and expert perspectives to empower biotech leaders like you.


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.

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