Regulatory & Submission Support
AI-assisted submissions built for FDA, EMA, and ICH.
Streamline the preparation, validation, and submission of regulatory packages with AI-assisted document generation and compliance checking — designed around FDA, EMA, and ICH guidelines to reduce review cycles and minimize submission errors.
Regulatory submissions represent the culmination of years of clinical work — and the point at which data quality, documentation completeness, and compliance precision matter most. A single gap in CDISC conformance, an inconsistency in the clinical study report, or a missing Define.xml element can trigger an FDA information request that delays approval by months. Bracy Analytics applies AI and automation to the submission preparation process: automated compliance checking against current FDA and EMA technical specifications, AI-assisted CSR generation, regulatory intelligence tools that identify gaps before submission, and CDISC validation pipelines that catch issues programmatically rather than in review. Our team brings deep familiarity with FDA, EMA, and ICH requirements — and the technical infrastructure to operationalize that knowledge at scale.
What We Deliver
Automated NDA / BLA / MAA Package Preparation
Programmatic assembly and validation of regulatory submission packages — including eCTD structure, dataset packages, analysis data reviewer guides (ADRGs), and supporting documentation.
CDISC Compliance Validation
Automated validation of SDTM, ADaM, and Define-XML against CDISC rules, FDA/PMDA validator requirements, and current FDA technical conformance guides — with issue tracking and resolution workflows.
AI-Assisted Clinical Study Report Generation
AI tools that accelerate CSR drafting by generating statistical results narratives, populating standard sections from analysis outputs, and flagging inconsistencies between text and tables.
Regulatory Intelligence & Gap Analysis
Systematic review of submission packages against current FDA, EMA, and ICH guidance — identifying compliance gaps, missing elements, and potential review issues before submission.
Analysis Data Reviewer Guide (ADRG) Authoring
Automated generation of ADRGs and dataset specification documents that guide FDA reviewers through the analysis data package — reducing information requests and review burden.
Post-Market Regulatory Analytics
Analytics support for post-market commitments, REMS programs, and periodic safety update reports (PSURs) — including signal detection, aggregate safety analysis, and benefit-risk assessment.
Real-World Applications
A pharmaceutical company is preparing an NDA for a novel oncology therapy and needs CDISC-compliant datasets and documentation within 12 weeks of database lock.
Automated CDISC validation and ADRG generation compress the submission preparation timeline, with all compliance issues identified and resolved before FDA submission.
A biotech company receives an FDA information request citing SDTM conformance issues in a previously submitted BLA.
Rapid CDISC gap analysis identifies all conformance issues, with corrected datasets and updated documentation prepared and submitted within the FDA response window.
A sponsor needs a clinical study report drafted for a 1,800-patient Phase III study with results across 40 endpoints.
AI-assisted CSR generation populates statistical results sections from analysis outputs, reducing drafting time by 40% while maintaining full accuracy and consistency.
A regulatory consulting firm needs to scale its CDISC programming capacity to support a surge in client submission timelines.
Automated validation and metadata-driven programming utilities deployed across client programs, enabling the firm to handle 3x the submission volume without proportional headcount growth.
Ready to Discuss Regulatory & Submission Support?
Our team will assess your program context and design a solution scoped to your data environment, regulatory obligations, and timelines.