Regulatory Affairs

Unparalleled precedent analysis, novel strategy development, and actionable insights powered by Catalytic Intelligence

Run Al-powered workflows that analyze millions of pages of precedent data to identify the changing signals that guide your strategy. All findings are traceable and delivered within a compliant, governed environment.

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Can keyword search and chatbots do this?

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Auto-generate regulatory background packets (RBP)

Enter your disease indication(s), therapeutic class, geographic regions, stages of development (Phase 1-Approved), and timespan then let the Catalytic workflows draft a detailed RBP in seconds.

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Find accelerated review paths through disease adjacency analysis

Implement multi-agentic workflows and to identify disease and MOA pairs similar to your therapy. Mine the regulatory history of similar pairs to identify accelerated paths and build an evidence based filing strategy.

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Quickly compare regulatory guidance across multiple geographies

Use natural language to describe your guidance question and geographic regions. Al-powered workflows will know which documents to analyze, what information to extract, and will deliver a compartive summary with citations

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Model predictive outcomes based on precedent data and competitive landscape

Catalytic's Al agents learn regulations and predict future outcomes based on input varibles. For example, predict the probability of gaining priority review designtion based on your therapy's projected clinical efficacy and safety profile compared to approved therapies and experimental clinical candidates.

Accurate. Reliable. Fast.

Ramp your team's productivity, insights, and deliverables with compliant Al designed for regulatory work.

Can keyword search and chatbots do this?

News & Insights

Auto-generate regulatory background packets (RBP)

Enter your disease indication(s), therapeutic class, geographic regions, stages of development (Phase 1-Approved), and timespan then let the Catalytic workflows draft a detailed RBP in seconds.

Find accelerated review paths through disease adjacency analysis

Implement multi-agentic workflows and to identify disease and MOA pairs similar to your therapy. Mine the regulatory history of similar pairs to identify accelerated paths and build an evidence based filing strategy.

Identify proven regulatory strategies with global precedent mining

Execute complex multi-concept searches across decades of global regulatory precedent data and choose how to view your returns - table, text or graphs. Your search threads are held in memory increasing context aware returns that can be added to reports with a single click and instantly validated against source documents.

Quickly compare regulatory guidance across multiple geographies

Use natural language to describe your guidance question and geographic regions. Al-powered workflows will know which documents to analyze, what information to extract, and will deliver a comparative summary with citations

Model predictive outcomes based on precedent data and competitive landscape

Catalytic's Al agents learn regulations and predict future outcomes based on input variables. For example, predict the probability of gaining priority review designtion based on your therapy's projected clinical efficacy and safety profile compared to approved therapies and experimental clinical candidates.

Your digital control tower for compliant AI

Global Regulatory Data Foundry

Global Regulatory Data Foundry

One centralized database of precedent data spanning drug labels, approval packets guidance documents. HA press releases, clinical trials, AdComm minutes. treatment guidieines, pathway data, and more

Conversational Interface

Conversational Interface

No code or complex interfaces in your way. Simply enter your queries. prompts, and requests in the regulatory language you use everday and the Catlalytic platform will get to work

Multi-Agent Platform

Multi-Agent Platform

We understand Al models are improving rapidly and some are better at certain tasks than others. We've built the Catalytic Platform to ensure the best suited Al is operating on your workflows and the most recent and best performing technology is always available to your organization.

Security and Compliance

Security and Compliance

Catalytic implements industry leading VPC architecture and robust virtual private networks to ensure all customer data remains secure both at rest and in transit. We will launch the Catalytic platform in your organization's cloud infrastructure or establish one for you. Our VPCs and workflows are GxP compliant from day one

Global Regulatory Data Foundry

Global Regulatory Data Foundry

One centralized database of precedent data spanning drug labels, approval packets guidance documents. HA press releases, clinical trials, AdComm minutes. treatment guidieines, pathway data, and more

Conversational Interface

Conversational Interface

No code or complex interfaces in your way. Simply enter your queries. prompts, and requests in the regulatory language you use everday and the Catlalytic platform will get to work

Global Regulatory Data Foundry

Global Regulatory Data Foundry

One centralized database of precedent data spanning drug labels, approval packets guidance documents. HA press releases, clinical trials, AdComm minutes. treatment guidieines, pathway data, and more

Conversational Interface

Conversational Interface

No code or complex interfaces in your way. Simply enter your queries. prompts, and requests in the regulatory language you use everday and the Catlalytic platform will get to work

Multi-Agent Platform

Multi-Agent Platform

We understand Al models are improving rapidly and some are better at certain tasks than others. We've built the Catalytic Platform to ensure the best suited Al is operating on your workflows and the most recent and best performing technology is always available to your organization.

Security and Compliance

Security and Compliance

Catalytic implements industry leading VPC architecture and robust virtual private networks to ensure all customer data remains secure both at rest and in transit. We will launch the Catalytic platform in your organization's cloud infrastructure or establish one for you. Our VPCs and workflows are GxP compliant from day one

Governance

Routine Agent validation and explainable, traceable, and auditable returns create transparency and trust. Al-powered firewalls enforce company-specific input/output rules and daily logs help ensure compliance requirements are met.

Global Regulatory Data Foundry

Al-ready foundry of global precedent data spanning drug labels, approval packets, HA press releases, guidance documents, clinical trials, AdComm meetings, treatment guidelines, pathway data, and more.

Secure and Compliant

Industry-leading VPC architecture and robust virtual private networks ensure all data remains secure at rest and in transit. Whether using our cloud or yours, proprietary hosted models, third-party models, or proprietary vector stores for in-house data, everything is integrated within one secure GxP compliant SSO-controlled VPC.

Global Regulatory Data Foundry
Conversational Interface

No code conversational interface enables users to use their language to engage with Al the same way they would talk to a trusted colleague.

Multi-Agent Platform

Al models are improving rapidly and some are better at certain tasks than others. We've built the Catalytic Intelligence Platform to ensure the best suited Al is operating on your workflows and the best performing technology is always available to your organization.

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

Senior Regulatory Affairs Strategist

Global Pharmaceutical 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

Frequently asked Questions

Which AI models do you use?

We are a multi-model technology stack and implement major foundation models, hosted proprietary models, and third-party models. Our selection of model is determined by the job to be done in a workflow and a partner’s security requirement.

How do you ensure AI outputs are accurate?

We create SME-curated ground truth datasets across diverse regulatory content and geographic regions. This expert curated ground truth data is used to benchmarkour models, validate returns, and revalidate upon model of vector store updates.

Do you provide access to source documents to verify returns?

Yes, all returns on the Catalytic Intelligence platform provide easy click-through to the source documents.

How often do you update your data?

We update many sources daily. If Health Authorities issue labels for new approvals, label expansions, Guidance documents, approval packets, etc. they will be ingested within 24 hours, QA’d, and accessible to users.

How often do you update your models?

We update models on an as needed basis. If new functionality is required by partners or models are deprecated, we will validate new models and deploy accordingly.

How do partners access your platform?

We will stand up a secure VPC within a partner’s cloud environment or provide access to a secure VPC within our cloud environment. We can accommodate your Company’s needs.

How do you handle proprietary partner data?

We establish hosted vector databases inside our partner’s cloud environment and ingest their data into their private and secure vector database. No customer data is ever exposed outside their VPC or used to train or validate models, ever.

How is your platform governed?

We built explainability, traceability, auditability, daily user logs, workflow tracking, and other governance modules into Catalytic Intelligence from the ground up. Partners can implement some or all the governance modules depending on their requirements.

How do you support your partners?

Catalytic delivers enterprise grade support through dedicated customer success teams, dedicated infrastructure and platform engineering teams, dedicated QA teams, and dedicated SMEs that work in Product to ensure required customizations are understood and delivered. These dedicated resources provide tiered support based on your requirements.

Is your platform compliant for regulatory use?

Yes, the platform is GxP, CFR part 11, HIPAA, and GDPR compliant from day one.

Do you integrate with popular storage and regulatory information management systems?

Yes, we integrate with the popular storage solutions and information management systems. We build custom APIs when needed to accommodate proprietary in-house systems and third-party systems on an as needed basis.

Connect with Catalytic

See how we're changing the future of life sciences regulatory affairs and CMC bioanalytical development and begin to imagine all the places Catalytic Intelligence can take you.

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Empowering life sciences with the tools to transform data into action. Because better decisions start with better intelligence.

Catalytic Data Science
Wilton, CT 06897

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