AI-powered platform that automates regulatory document preparation and consolidation for Investigational New Drug (IND) submissions in biotechnology.
Biotechnology companies spend months preparing documentation required for Investigational New Drug (IND) submissions, with most time devoted to organizing results, rewriting information across multiple documents, and maintaining consistency. Manual document assembly processes employed by Contract Research Organizations extend timelines and increase costs, while every data update requires repeating the same consolidation work, further delaying trials.
Biotechnology companies spend months preparing documentation required for Investigational New Drug (IND) submissions, with most time devoted to organizing results, rewriting information across multiple documents, and maintaining consistency. Manual document assembly processes employed by Contract Research Organizations extend timelines and increase costs, while every data update requires repeating the same consolidation work, further delaying trials.
Scoop uses artificial intelligence agents to automate the manual consolidation and document preparation required for IND submissions. The platform converts existing study and manufacturing data into draft regulatory documents with full traceability, automatically flags inconsistencies, and updates affected sections as new data arrives, reducing submission preparation from months to days.
Scoop uses artificial intelligence agents to automate the manual consolidation and document preparation required for IND submissions. The platform converts existing study and manufacturing data into draft regulatory documents with full traceability, automatically flags inconsistencies, and updates affected sections as new data arrives, reducing submission preparation from months to days.
Appears active as of 2025 based on Y Combinator listing and company website.
Event Year: 2025
Appears active as of 2025 based on Y Combinator listing and company website.
Event Year: 2025
Scoop is an artificial intelligence-powered platform designed to accelerate the drug development process by automating regulatory submissions for life sciences companies. The platform transforms how biotechnology firms prepare documentation required for Investigational New Drug (IND) submissions, reducing timelines from months to days while maintaining regulatory compliance and consistency.
Biotechnology companies face significant operational bottlenecks when preparing regulatory submissions. The process of compiling and organizing documentation for IND filings requires extensive coordination across multiple teams, contractors, and internal departments. Companies typically spend months consolidating study reports, manufacturing data, and supporting documents into the required submission format. This manual, time-consuming process delays the initiation of crucial first-in-human trials and increases development costs before any patient treatment begins. Contract Research Organizations (CROs) that assist with clinical trials often employ manual document assembly processes, further extending timelines and escalating expenses.
Scoop is an artificial intelligence-powered platform designed to accelerate the drug development process by automating regulatory submissions for life sciences companies. The platform transforms how biotechnology firms prepare documentation required for Investigational New Drug (IND) submissions, reducing timelines from months to days while maintaining regulatory compliance and consistency.
Biotechnology companies face significant operational bottlenecks when preparing regulatory submissions. The process of compiling and organizing documentation for IND filings requires extensive coordination across multiple teams, contractors, and internal departments. Companies typically spend months consolidating study reports, manufacturing data, and supporting documents into the required submission format. This manual, time-consuming process delays the initiation of crucial first-in-human trials and increases development costs before any patient treatment begins. Contract Research Organizations (CROs) that assist with clinical trials often employ manual document assembly processes, further extending timelines and escalating expenses.
Subscription-based software-as-a-service (SaaS) with enterprise pilots and demonstrations for regulatory teams and CROs.
Subscription-based software-as-a-service (SaaS) with enterprise pilots and demonstrations for regulatory teams and CROs.
Pharmaceutical companies, biotechnology firms, regulatory affairs professionals, Contract Research Organizations (CROs), and clinical trial consultants.
Pharmaceutical companies, biotechnology firms, regulatory affairs professionals, Contract Research Organizations (CROs), and clinical trial consultants.
Company listed as active on Y Combinator in 2025 with operational website.
Hiring: unknown
Company listed as active on Y Combinator in 2025 with operational website.
Hiring: unknown
Scoop leverages artificial intelligence agents to automate the manual consolidation and document preparation required for every IND submission. The platform converts a biotech's existing study, manufacturing, and support documents into draft regulatory submission text while maintaining full traceability. Each sentence in the generated documents is linked back to its source material, enabling regulatory teams to verify accuracy and compliance. The system automatically flags inconsistencies and updates affected sections as new data arrives, eliminating the need to repeat manual work with each data update.
Scoop leverages artificial intelligence agents to automate the manual consolidation and document preparation required for every IND submission. The platform converts a biotech's existing study, manufacturing, and support documents into draft regulatory submission text while maintaining full traceability. Each sentence in the generated documents is linked back to its source material, enabling regulatory teams to verify accuracy and compliance. The system automatically flags inconsistencies and updates affected sections as new data arrives, eliminating the need to repeat manual work with each data update.
The platform currently focuses on drafting Module 2 and Module 3 narratives for IND submissions, which represent critical components of regulatory filings. By generating draft documents in the required structure and maintaining consistency across all materials, Scoop enables teams to focus on approving content rather than assembling it from scratch.
The platform currently focuses on drafting Module 2 and Module 3 narratives for IND submissions, which represent critical components of regulatory filings. By generating draft documents in the required structure and maintaining consistency across all materials, Scoop enables teams to focus on approving content rather than assembling it from scratch.
Scoop provides automated document generation for regulatory submissions with real-time compliance tracking to ensure submissions meet regulatory requirements. The platform includes collaboration tools designed for cross-functional teams, allowing regulatory affairs professionals, scientists, and compliance specialists to work together efficiently. Integration with electronic lab notebooks (ELNs) enables seamless data flow from laboratory systems into regulatory documents. Customizable submission workflows allow companies to tailor the platform to their specific regulatory processes and requirements.
Scoop provides automated document generation for regulatory submissions with real-time compliance tracking to ensure submissions meet regulatory requirements. The platform includes collaboration tools designed for cross-functional teams, allowing regulatory affairs professionals, scientists, and compliance specialists to work together efficiently. Integration with electronic lab notebooks (ELNs) enables seamless data flow from laboratory systems into regulatory documents. Customizable submission workflows allow companies to tailor the platform to their specific regulatory processes and requirements.
The platform serves pharmaceutical companies, biotechnology firms, and regulatory affairs professionals seeking to streamline their submission processes. Primary use cases include automating regulatory submissions, managing document workflows, streamlining compliance processes, and generating regulatory reports. Scoop targets small and mid-sized biotechs through both direct sponsors and CRO partnerships, positioning itself as a solution for companies looking to modernize their submission workflows and accelerate drug development timelines.
The platform serves pharmaceutical companies, biotechnology firms, and regulatory affairs professionals seeking to streamline their submission processes. Primary use cases include automating regulatory submissions, managing document workflows, streamlining compliance processes, and generating regulatory reports. Scoop targets small and mid-sized biotechs through both direct sponsors and CRO partnerships, positioning itself as a solution for companies looking to modernize their submission workflows and accelerate drug development timelines.
Scoop operates on a subscription-based pricing model, with plans starting at forty-nine dollars per month. The platform is delivered through demonstrations and enterprise pilots to regulatory teams and CRO consultants, allowing companies to evaluate the solution before full implementation.
Scoop operates on a subscription-based pricing model, with plans starting at forty-nine dollars per month. The platform is delivered through demonstrations and enterprise pilots to regulatory teams and CRO consultants, allowing companies to evaluate the solution before full implementation.
Scoop's focus on the life sciences sector and regulatory compliance represents a notable differentiator in the market. The platform's ability to maintain full traceability while automating document generation addresses a critical pain point in the regulatory submission process. By reducing submission preparation timelines from months to days, Scoop enables biotechnology companies to accelerate their path to human trials and reduce pre-clinical development costs.
Scoop's focus on the life sciences sector and regulatory compliance represents a notable differentiator in the market. The platform's ability to maintain full traceability while automating document generation addresses a critical pain point in the regulatory submission process. By reducing submission preparation timelines from months to days, Scoop enables biotechnology companies to accelerate their path to human trials and reduce pre-clinical development costs.
