Exalon is a leading specialist in PDF publishing for highly complex scientific and regulatory documents, including large‑scale Clinical Study Reports (CSRs). Depending on study design and alignment with ICH E3 guidance, CSRs can exceed 50,000 pages, combining detailed main sections with hundreds or thousands of tables, figures, and listings in the appendices.
Professional PDF Publishing for Clinical and Nonclinical Study Reports
With more than 25 years of experience supporting pharmaceutical companies, CROs, and research organizations, Exalon provides high‑quality, submission‑ready PDF publishing services for clinical and nonclinical study documentation. Our expertise includes:
eCTD‑Ready PDF Publishing
- Fully bookmarked and hyperlinked study reports prepared for regulatory submissions
- Delivery as a single PDF or in granular structures required for US eCTD submissions and Study Tagging Files (STFs)
- Integration of customer‑specific formatting, including headers/footers, pagination models, and layout conventions
Advanced, Cost‑Effective, and Reliable Publishing Workflows
Exalon’s proprietary publishing solution allows us to tailor the degree of automation to each individual project, ensuring cost‑effective, scalable, and highly reliable results — even for extremely large and complex reports.
Key advantages of our semi‑automated publishing process:
- Consistent high quality across all document components
- Fast updates of individual report sections without losing previously completed work
- Flexible automation levels to meet complexity, timelines, and regulatory requirements
- Full compliance with global submission standards, including eCTD and related guidelines
Our optimized workflow delivers efficiency, precision, and superior consistency, making it ideal for regulatory submissions in global markets.