Compilation and validation using global publishing tools (e.g., Lorenz, Veeva RIMS)

Regulatory Operations

eCTD Publishing and Submission Services

At Techsol Life Sciences, we understand that successful regulatory submissions begin with robust eCTD validation. Each health authority has its own set of validation rules, technical requirements, and region-specific compliance standards. Our specialized eCTD validation services ensure that your dossiers are error-free, technically sound, and submission-ready.

Key Capabilities:

Conversion of source documents to submission-ready formats (PDF compliance, TOCs, bookmarks, hyperlinks)
eCTD module compilation and document granularity alignment
Integration of study data (SAS outputs, datasets, CRFs) and trial information into eCTD structure

Our team is experienced in global publishing platforms, including:

Lorenz docuBridge
Veeva Vault RIMS
EXTEDO eCTD manager

What We Do in Validation of eCTD Sequences:

Our expert publishing team performs thorough validation of eCTD sequences using industry-recognized tools to check for:

If validation errors are identified, our team:

Diagnoses root causes of technical failures
Rectifies issues in document placement, file naming, sequence structure, or metadata
Performs re-validation until all errors and warnings are cleared

Validation of sequences against region-specific standards (e.g., US FDA, EMA, Health Canada, PMDA)
Use of Lorenz eValidator and other validation tools to detect technical errors before final submission
Generating and reviewing validation reports to ensure readiness