2026-02-12
Regulatory authorities are integrating generative AI into their internal review processes. This changes how submissions are examined, even though the underlying scientific and evidentiary expectations remain the same.
As review becomes more systematic and comparative, expectations for clarity, internal consistency, and well-documented reasoning increase. This white paper examines what machine-assisted review means in practice and how sponsors can prepare.
Scientific Editor
Scientific Editor
Ingela Loell is a Scientific Editor at SSI Strategy with more than 10 years of experience in scientific and regulatory communication. Holding a Ph.D. in Rheumatology from Karolinska Institutet, she specializes in translating complex biomedical science into clear, structured content for biotech and pharmaceutical audiences. Her work includes thought leadership, regulatory intelligence, and scientific documentation, developed in close collaboration with subject matter experts. She also supports AI-enabled innovation initiatives focused on improving the quality and efficiency of scientific content development.
President & Chief Innovation Officer
President & Chief Innovation Officer
Johan Strömquist is President & Chief Innovation Officer at SSI Strategy and a published author on AI and risk management. With over 25 years of leadership experience across IT, life sciences, and consultancy, Johan specializes in guiding organizations through innovation, digitalization, and regulatory complexity. He co-founded Metalmind in 2023, focusing on AI productivity, and leads SSI Strategy’s innovation initiatives within biopharma. His expertise spans regulatory affairs, benefit–risk assessment, GDPR compliance for life sciences, and the application of generative AI in business. Johan thrives on managing change, fostering growth, and helping organizations achieve their goals.
He is the author of The Book on AI Risk Management – A Guide for Modern Executives.
Key areas of expertise
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
