CSR Review & Module Preparation
Streamline your regulatory submissions with our expert Clinical Study Report (CSR) review, CTD module assembly, and comprehensive clinical/non-clinical summaries. We ensure GCP/GLP-compliant documentation that meets ICH E6(R3), FDA, EMA, and CDSCO standards, accelerating IND/NDA/ANDA approvals.
CSR Review & Finalization
Thorough gap analysis and peer review of CSRs per ICH E3 guidelines, covering synopses, methodology, efficacy/safety results, biostatistics, and appendices. We resolve discrepancies in AE coding (MedDRA), PK/PD analyses, and protocol deviations, delivering inspection-ready reports with executive summaries and patient narratives.
CTD Module Preparation
Complete Module 2 (CTD summaries) and Module 5 (clinical reports) assembly, integrating CSRs, IB updates, and literature references. Non-clinical Module 4 includes pharmacology, PK/ADME, and toxicology reports formatted for eCTD submissions, with hyperlinked appendices and standardized templates.
Clinical & Non-Clinical Overviews
Author Module 2.5 clinical overviews (CO) synthesizing Phase I-III data, benefit-risk assessments, and subpopulation analyses. Non-clinical overviews (2.4) consolidate repeat-dose tox, genotox, repro tox, and safety pharmacology, highlighting NOAELs, qualifiers, and human relevance for regulatory queries.
Toxicology Study Reports
GLP-compliant tox report authoring for acute, sub/chronic, carcinogenicity, and developmental studies in rodents/non-rodents. We include histopathology, clinical pathology, and ADME data with tabular NOEL/LOEL derivations, risk assessments, and CTD-ready formatting for M4.2.3/4 sections.