Products

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 AI-powered application for monitoring regulatory guideline changes, requirement updates, precedent decisions, and their impact on pharmaceutical product portfolios.

An application for managing post-approval regulatory variations — including variation classification, submission preparation, and cross-jurisdiction tracking for marketed pharmaceutical products.

An application for managing pharmaceutical product labeling — including core data sheet management, local market adaptation, artwork coordination, and change impact analysis.

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 automated pharmaceutical traceability reporting across jurisdictions — supporting DSCSA, EU FMD, India DCTS, and other regulatory frameworks.

An application for managing the adverse event lifecycle — from intake and assessment through regulatory reporting, signal detection, and health authority submission.

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-assisted application for drafting clinical study reports — providing section-level drafting, quality review per ICH E3, cross-reference validation, and multi-stakeholder review workflows.

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

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.

Validate UDI Excel for EUDAMED and FDA GUDID—fast, precise, and fully in the cloud. The UDI Excel Cloud Validator helps MedTech teams catch format and content issues before submission. You sign in via browser, select the target authority, and upload your Excel file. Within seconds, the app returns row-level feedback with clear hints on how to fix each finding. When you’re ready, you can download a detailed Excel or CSV report for review and collaboration.

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

Com School Management Software is a comprehensive software designed for managing schools and educational institutions

A APIPASS é a solução em integração que vai dar fluidez para sua operação. Nosso trabalho é simplificar suas integrações complexas para acelerar os resultados de sua transformação digital. Com o iPaaS da APIPASS você integra com o mínimo de código, uma solução low-code, com interface simples e fácil, com mais de 700 conectores pronto e de fácil ativação. Nossa tecnologia diferenciada, permite sermos a única plataforma brasileira que roda on-premise, no cloud provider que você usa e na nuvem AWS.

NetWave Retail Management gives you what you need to control all of your showrooms, warehouses and sales staff. Netwave Retail gives you the power to control the processes taking place in your retail business.

Clinic Essentials is a clinic management solution designed with features and interfaces to help you manage your daily tasks such as scheduling, invoicing, reporting, and managing inventory.

ClinixPM is a practice management software that helps you manage your practice's claims, cashflow with automated, customizable features such as revenue functionality, analysis of practice performance with reports, and more.

ADOC is a solution that provides plan maintenance and tracking of the aircraft with its components in accordance with the requirements of CAMO.