Regulatory submissions, pharmacovigilance, and clinical trial management are expensive, slow, and high-stakes. NOVA understands the language of drug regulation - and takes on the heaviest tasks so your team can focus on what matters.
Compiling a CDSCO, FDA, or EMA dossier means reading hundreds of documents, identifying gaps, formatting sections to exact specifications - consuming months of your regulatory affairs team's time.
Pharmacovigilance obligations never stop. Adverse event reports arrive continuously, require MedDRA coding, signal assessment, and timely routing - the consequences of a missed signal are severe.
Managing site activation, patient recruitment, and protocol deviations across dozens of trial sites using spreadsheets creates dangerous visibility gaps.
CDSCO, FDA, EMA, and WHO publish guidance updates constantly. Tracking every change and assessing its impact on your products is a continuous burden.
Batch release validation, GMP documentation, and GLP records are produced manually - creating inconsistency, version control problems, and audit exposure.
Most organisations prepare for regulatory inspections reactively - scrambling to compile documentation when an inspection is announced.
Reads your clinical study reports and product data, identifies gaps for CDSCO, FDA, or EMA, and compiles the complete regulatory dossier in the correct format. Your team reviews and submits - not rebuilds.
Monitors all adverse event reports continuously - classifying signals, applying MedDRA codes, and routing to the right reviewer. Complete audit trail on every signal processed.
Replaces spreadsheet chaos with a single live dashboard - site activation, patient recruitment, protocol adherence, and deviations automatically flagged for review.
Reads new regulatory guidance from CDSCO, WHO, FDA, and EMA continuously - assesses impact on your products - and tells your team exactly what needs to change.
Plans, authors, and manages regulatory submissions across multiple health authorities simultaneously - tracking status and managing response timelines.
Reviews batch manufacturing records, QC test results, and deviation reports against approved specifications. Generates a complete release decision summary for your QP.
Monitors GxP compliance across your documents, processes, and systems continuously - not just at audit time. Identifies gaps and tracks corrective actions.
Maintains your audit trail automatically. When an inspection is announced, AuditIQ produces your full evidence package in hours rather than weeks.
Detects pharmacovigilance signals from safety databases and literature using validated statistical detection methods - routing confirmed signals through your risk management process.
NOVA is not a general AI told to act like a pharma expert. It is trained on CDSCO, FDA 21 CFR, EMA guidelines, ICH E2A–E2F, MedDRA terminology, eCTD v4.0, and GMP/GLP/GCP frameworks.
Deep dive into NOVA →Semantic search across regulatory guidelines, ICH documents, and your dossier archive - finds precise answers using regulatory terminology.
Scores regulatory options and risk scenarios using pharma-specific logic - every recommendation comes with clear reasoning and documented evidence.
Reads clinical study reports, safety narratives, batch records, and regulatory correspondence - extracting structured information for RegIntel and AuditIQ.
Compares your dossier sections and SOPs against CDSCO, FDA, and EMA requirements - producing a detailed gap list and remediation checklist.
Identifies pharmacovigilance signals using validated statistical methods - the core detection engine behind SafeWatch and SignalIQ.
Generates an immutable, time-stamped audit trail on every action - creating the traceable evidence record health authority inspectors require.
Share existing dossiers, safety databases, clinical study reports, and SOPs. Connect your document management system through standard APIs. Everything is indexed in your private, isolated environment.
RegIntel starts reviewing your dossier against current authority requirements. SafeWatch begins monitoring your safety database. ClinTrialOps AI starts tracking your trial sites. ComplianceGuard AI monitors regulatory guidance. All running continuously from day one.
Instead of creating documents from scratch, your regulatory team reviews what NOVA has prepared. Every submission is traceable, every signal documented, every compliance gap already actioned.