CTD authoring (Modules 2–5) is a high-stakes, time-consuming process under constant time pressure, with multiple contributors and frequent late-stage changes.
Content is scattered across source documents (study reports, protocols, CMC, safety updates, literature, prior submissions) and teams, making consolidation, consistency, and version control difficult.
Ensuring traceability of every statement, maintaining alignment across sections, and staying compliant with regulatory expectations are essential — yet costly to sustain across iterations, variations, and responses to questions.
2× faster dossier drafting
Reduce first-draft timelines by up to 2× by generating CTD sections directly into governed templates from a consolidated evidence pack.
Fewer inconsistencies across modules
Improve alignment between summaries and source documents to cut review cycles and prevent contradictory statements that delay submission.
Audit-ready, source-linked content
Maintain defensible traceability for every claim with citations and run records — improving inspection readiness and accelerating approvals.
How it works
1
Build your CTD templates in Biolevate — define standardized structures for key CTD sections (e.g., overviews, summaries, quality/CMC narratives) and attach writing rules, style, and regulatory guidance at the section level.
2
Ingest and structure the evidence pack — consolidate inputs (CSRs, protocols, SAPs, CMC docs, safety updates, references, prior submissions) so Biolevate can map evidence to the right CTD sections with traceability.
3
Generate first standardized CTD drafts — Biolevate populates your governed templates according to the attached guidelines, producing consistent narratives, tables, and references with source-linked claims.
4
Review, respond, and update faster — teams validate and refine; then reuse the same governed templates + evidence base to accelerate variations, lifecycle updates, and responses to agency questions with consistent quality.
Template + guideline governance: reusable CTD section templates with embedded guidance to standardize dossiers across products and regions.
Cross-module consistency: ensure alignment across summaries, clinical, quality, and safety narratives to reduce contradictions and rework.