An Investigational New Drug (IND) submission demands evidence from Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), stability, and analytical systems — assembled with full lineage traceability. The ZONTAL IND Wizard compiles a submission-ready electronic Common Technical Document (eCTD) package with auto-inserted cross-references across all source systems. What used to take months takes weeks.
An IND submission requires assembling evidence from LIMS, ELN, Manufacturing Execution Systems (MES), stability databases, and vendor analytical software into a coherent regulatory package with full traceability. Today, regulatory scientists spend 4–6 months manually copying data between systems, cross-referencing results, and reconstructing lineage from final assay back to raw instrument output. A single missing reference can trigger a Complete Response Letter — and 65% of CRLs cite manufacturing data deficiencies (FDA CRL analysis).
Manually compiles eCTD Module 3.2 packages — copying stability reports from one system, analytical certificates from another, and batch records from a third, then cross-referencing every table and figure citation by hand. A single missed reference risks a Complete Response Letter.
Coordinates IND timelines across analytical, stability, manufacturing, and regulatory teams at multiple sites — but has no single view of which data packages are complete, which are pending, and which have gaps that will delay filing.
Generates the characterization and method validation data that feeds Module 3.2.S.4. Runs dissolution, impurity profiling, and reference standard qualification — but the results sit in vendor-specific CDS and LIMS exports until someone manually extracts and reformats them for the submission package.
Each stage of the ZONTAL platform contributes a specific capability to IND acceleration. Together they transform months of manual assembly into a governed, AI-assisted compilation workflow.
Integration factories extract data from every source system — LIMS, ELN, MES, stability LIMS, analytical instruments — with full provenance. Every data point is traced to its source instrument and run.
Sample genealogy connects batch → sample → method → result in a governed context graph. Cross-system identity reconciliation builds the lineage map that ICH CTD modules require.
Stability trending, comparability analysis, and anomaly detection surface insights that manual review misses. AI-assisted recommendations identify what to include and what to investigate before compilation.
Define scope, select governed data, configure templates, and generate a submission-ready eCTD package — documents analyzed, cross-references auto-inserted, months of manual effort eliminated.
Each capability adds to the next. Remove any one and the IND Wizard loses its foundation.
IND Acceleration requires all four capabilities working in
concert.
Evaluate readiness with the five-question
framework →
Data Hub connects 150+ vendors and 400+ instrument models through governed Integration Factories. Every data point is validated and traced from source instrument to scientific context with full provenance. Data Hub converts and normalizes governed data from every source system — analytical instruments, LIMS, ELN — with filing-relevant provenance at scale.
Digital Lab and Platform Modules build the scientific context graph — ontology mapping, cross-system identity reconciliation, and full lineage from instrument through result to insight. The lineage graph connects batch, sample, method, and result with ICH CTD module mapping built into the context from the start.
Cross-program analytics surfaces trends, anomalies, and predictive signals that manual review misses — proven AI capabilities running on governed, validated scientific data. Analytics surfaces cross-program trends, stability predictions, and anomaly signals that inform evidence selection for regulatory packages.
AI-assisted workflows consume governed data, scientific context, and intelligence to generate actionable outputs — with configurable oversight from full autonomy to human-in-the-loop approval gates. The IND Wizard consumes all three principles to generate submission-ready regulatory packages with auto-references and completeness scoring.
Published content from pharmaceutical and agrochemical companies solving real scientific data challenges.
Trusted by 6 of the 10 largest pharmaceutical companies in the world
And leading biotechs and agrochemical companies
“The critical path is CMC. We need to iterate faster: run experiments, quickly analyze data, propose the next experiment — or even predict results.”
Walk through how governed data across every capability will become a submission-ready eCTD package — and plan the data foundation your pipeline needs today.
