Regulatory Affairs

Regulatory Strategy: The foundation of successful drug development 

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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. 

SERVICE LEADERSHIP

Laurie Smaldone Alsup

SVP Regulatory Services

Laurie Smaldone Alsup

SVP Regulatory Services

Laurie Smaldone Alsup, MD, is an expert in global clinical development and regulatory strategy with a focus on accelerating innovative therapies to patients. A physician executive trained in Internal Medicine and Medical Oncology at the Yale School of Medicine, Laurie brings more than 30 years of global experience in pharmaceutical and biotechnology leadership including biotechnology board experience She advises companies on regulatory and clinical strategies to support product approvals in the U.S. ,Europe and globally with a successful track record across numerous disease indications, including oncology, infectious diseases, immunology, neurology and rare genetic disorders. Laurie previously held senior executive roles at Bristol-Myers Squibb PharmApprove, NDA Group and Phytomedics, guiding numerous products through development, approval, and commercialization worldwide. She currently sits on the board of two biotechnology companies.  

Key areas of expertise

  • Global Clinical Development & Regulatory Strategy 
  • Benefit–Risk Assessment & Product Lifecycle Management 
  • Leadership in Oncology, Immunology, Infectious disease, and Rare Disease Programs 
  • Corporate affairs, risk management and communications 
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Kim Forbes McKean

SVP

Kim Forbes McKean

SVP

Kim Forbes-McKean, PhD is a highly accomplished biotech and pharmaceutical executive with over 35 years of experience in global drug, device and drug-device combination product development. She currently serves as Senior Vice President, Regulatory & Strategy as part of the Regulatory Leadership Team at SSI Strategy. Throughout her career, she has combined deep scientific expertise with strong commercial acumen, successfully converting business units into profitable enterprises. Her leadership spans all phases of development for small molecules, biologics, and combination products, with regulatory successes in oncology, dermatology, inflammatory, auto-immune and rare diseases. Known for building operational infrastructure and high-performing R&D teams, Kim combines strategic vision with executional excellence to deliver transformative healthcare solutions aligned with client and project goals. 

Key areas of expertise

  • Global clinical/regulatory strategy and agency negotiations to secure expedited approvals 
  • Leadership in building cross-functional pharmaceutical development organizations for growth 
  • Drug and drug-device combination product development 
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Björn Carlsson

VP Regulatory Science

Björn Carlsson

VP Regulatory Science

Björn Carlsson is a seasoned regulatory affairs and clinical immunology expert with over 17 years in pharmaceutical development and regulatory strategy. As Vice President, Regulatory Science, he leverages 12 years at the Swedish Medicines Agency, including a decade as non-clinical assessor and two years leading a multidisciplinary clinical efficacy-safety group. In addition, he was the Swedish alternative delegate in the in the committee for advanced therapies (CAT) at the European Medicines Agency (EMA) for 9 years.  His expertise spans non-clinical development, Advanced Therapy Medicinal Products (ATMPs), and strategic regulatory planning, with a proven track record in scientific advice and complex authorisation procedures. Björn’s leadership in ATMP certification and cross-functional collaboration positions him as a key contributor to projects requiring deep regulatory insight and scientific rigor. 

Key areas of expertise

• Advanced Therapy Medicinal Products (ATMPs) 
• Regulatory strategy and scientific advice 
• Leadership of multidisciplinary clinical teams 

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