FDA Tracker by Leucine is an AI-powered platform that helps pharmaceutical and life sciences companies stay ahead of regulatory risks. With real-time insights into FDA inspection trends, 483 observations, and warning letters, FDA Tracker empowers teams to benchmark performance, uncover hidden risks, and proactively close compliance gaps—before the regulator comes knocking. Key Features Real-Time Inspection Data: Access the latest FDA inspections, 483s, and warning letters across facilities a
RetinAI's Real-World Evidence (RWE) solution empowers pharmaceutical and life sciences companies to harness comprehensive real-world data in ophthalmology. By analyzing extensive datasets, including over 225,000 high-quality patient records, RetinAI provides enriched insights into disease biomarkers, patient populations, and treatment trends. This facilitates informed decision-making across the entire product lifecycle, from clinical development to commercialization.
Access regulatory guidelines, guidance in key markets worldwide to compliment your ongoing regulatory affairs department for new product clinical development, product registration, product launch, pricing and reimbursement and post approval lifecycle maintenance. QuriousRI, Artixio’s regulatory intelligence software tool, comprehensively covers all applicable regulatory guidelines from health authorities and tracks regulatory updates in real time.
DDReg Pharma, a Global Regulatory Solutions and Safety Services organization is based out of Delaware in the US. The delivery of services currently happens from their India offices. They have a presence in Mumbai, Hyderabad, and Gurgaon. Incepted in the year 2009, the company is involved in a wide variety of regulatory & drug safety assignments across global markets. Rich subject matter expertise is combined with cutting-edge technology solutions providing end-to-end support across the pharm
Brand Liaison is a leading compliance consultancy firm helping manufacturers, importers, and global brands navigate India’s complex regulatory landscape. We specialize in certifications such as BIS, BEE, WPC, EPR, LMPC, TEC, and more, providing end-to-end support from documentation to approval.
Haulogy FLOW is a modular, energy-native SaaS suite designed to automate and optimize the entire meter-to-cash journey for modern energy suppliers. Built specifically for complex regulatory environments, the platform enables electricity and gas providers to accelerate innovation while maintaining rigorous margin control. Key capabilities: - Agile offer creation: Rapidly launch standard and advanced offers (including PPAs, collective self-consumption, and personalized dynamic pricing) without cu
School Central is simple school management software built for small Christian schools. Created by a Christian school principal out of real-world administrative needs, it helps schools manage admissions, student records, attendance, grades, parent communication, tuition tracking, and billing without the complexity or cost of enterprise systems.
Schools by Inkrant is an AI-native school management platform built for K-12 schools. It replaces multiple disconnected tools with one unified system covering admissions, attendance, fee management, timetable scheduling, grade books, and parent-teacher communication. Key capabilities include AI-powered automatic timetable generation that resolves conflicts in seconds, AI grading assistance for faster and more consistent assessment, smart notifications for parents via app and SMS, multi-branch s
CSR Automation Clinion’s CSR Automation is built on a native AI foundation, enabling medical writing teams to generate structured, compliant Clinical Study Reports with significantly less manual effort. By extracting content directly from Protocols, SAPs, and TLFs, it ensures consistency, accuracy, and faster turnaround. What can you expect? ● AI-Generated CSR Sections Automatically create structured CSR content by extracting key insights from study documents. ● Built-In Regulatory Compliance
Arancia is a cybersecurity and technology managed security service provider (MSSP) trusted by Fortune 500 brands to manage their cybersecurity and technology needs. The company operates on a partner-led model, offering expertise in consulting, managed security services, incident response forensics, and managed cloud technology. With a focus on various industries such as higher education, healthcare, and financial services, Arancia emphasizes the importance of a skilled team and innovative soluti
Zelthy Regulatory Affairs is an AI-powered regulatory authoring workspace for pharma and biotech companies preparing FDA and EMA dossier submissions. Every AI-generated sentence is grounded in imported source documents and every claim is traceable back to the source page and paragraph. AI agents work across the entire document library simultaneously, catching inconsistencies a human reviewer would miss across 100+ documents.
An application for organizing regulatory dossier content per ICH CTD structure — including document management, publishing validation, multi-stakeholder review, and submission package generation.
An application for managing pharmaceutical regulatory submission pipelines — providing unified tracking, milestone management, and health authority query coordination across jurisdictions.
An AI assistant for pharmaceutical compliance teams — providing regulatory Q&A grounded in SOPs, document compliance scoring, SOP drafting assistance, and policy gap analysis.
An application for managing pharmaceutical product labeling — including core data sheet management, local market adaptation, artwork coordination, and change impact analysis.
An AI-powered application for monitoring regulatory guideline changes, requirement updates, precedent decisions, and their impact on pharmaceutical product portfolios.
An application for managing the adverse event lifecycle — from intake and assessment through regulatory reporting, signal detection, and health authority submission.
An application for automated pharmaceutical traceability reporting across jurisdictions — supporting DSCSA, EU FMD, India DCTS, and other regulatory frameworks.
An AI-assisted application for drafting clinical study reports — providing section-level drafting, quality review per ICH E3, cross-reference validation, and multi-stakeholder review workflows.