The Future of Compliant AI in Regulated Workflows

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Our Mission

Our mission is to create technology that enables people < - > AI partnerships in therapeutic drug development. By combining advanced AI with expert human judgment, regulatory teams will become far more efficient, anticipate Health Authority changes, build novel strategies, streamline submissions, and outcompete teams comprised of either humans or AI alone.

A new way to scale teams

Our AI-powered workflows act as intelligent personal assistants for regulatory teams, streamlining complex processes, maximizing efficiency, and uncovering insights. We empower every employee to scale their daily work and enable teams to increase per-person productivity while achieving critical milestones faster, more cost efficiently, and compliantly.

Partner with our intelligent AI to mine ...

Stay Ahead of Evolving Guidance

Catalytic's intelligent Al Agents detect, mine and report on newly issued guidance documents and AdComm meetings to identify changing regultory sentiment so partners stay ahead of upcoming requirements

Avoid IND Delays

Catalytic's suite of capabilities enabled a partner to quickly add integration site analyses and functional annotation of off target edits resolving FDA concerns and preventing an IND delay.

Lift Clinical Holds

Catalytic's suite of capabilities enabled a partner to demonstrate a detected chromosomal abnormality in a clinical tial participant was not related to an editing event resolving a clinical hold in 90 days.

Strengthen Release Criteria

Catalytic's CMC Analytics Hub enabled a partner to seamlessly add structural variant and copy number vanant analyses to meet evolving release criteria requirements

4,110,218

SEC Filings

9,285,656

Patents

29,195,255

Open Access Scientific Literature

954

EMA Advisory Meeting Minutes

4,546

FDA Advisory Committee Documents:

1,468

FDA, EMA and PMDA Regulatory Guidance Documents

90,977

FDA & EMA Approval Packet Documents

77,825

FDA & EMA Drug Labels

543,357

US Clinical Trials

"Catalytic has become an invaluable source of critical information in helping our regulatory team build, execute, and adapt its strategy."

Senior Regulatory Affairs Strategist

Fortune 50 the sciences company

"Catalytic has become an invaluable source of critical information in helping our regulatory team build, execute, and adapt its strategy."

"Catalytic has become an invaluable source of critical information in helping our regulatory team build, execute, and adapt its strategy."

Senior Regulatory Affairs Strategist

Fortune 50 the sciences company

Who We Are

We’re an integrated team of life scientists, regulatory affairs SMEs, engineers, and designers who believe AI-powered workflows will transform therapeutic product development.

Our Values and Principles

Champion Our Customers

We understand the complexity of our customers work and the vital impact it has on patients’ lives. Their success drives everything we build and every decision we make.

Build True Partnerships

We work side by side with our customers as long-term partners, not transactional suppliers. Our commitment continues well beyond the initial engagement.

Think from First Principles

We apply first principles thinking and prioritize clear, transparent communication. This approach helps us cut through noise and solve problems at their root.

Keep Solutions Simple

We believe in practical, effective solutions over unnecessary complexity. Our work is guided by clarity, usability, and real-world results.

Tackle the Toughest Challenges

We take on hard problems others avoid, knowing they matter most. Solving these challenges enable customers to redefine what’s possible and light the way for industry advances.

Advance Responsible AI

We use AI to improve life sciences while prioritizing safety, compliance,and trust. Our models are tightly controlled and governed to meet rigorous regulatory standards.

Catalytic Careers

If you’re motivated by our mission and values, please reach out, we’d love to hear from you!