Preparation and publishing of regulatory dossiers in eCTD, NeeS, and paper formats

Regulatory Operations Services

eCTD Publishing & Submission

At Techsol Life Sciences, we specialize in the preparation of country-specific regulatory dossiers, ensuring full alignment with the latest health authority specifications and evolving global regulatory guidelines. Our comprehensive eCTD preparation and publishing services are designed to meet the submission requirements of major markets worldwide. With deep domain expertise across diverse regulatory frameworks, we support pharmaceutical and biotech companies in the preparation, compilation, publishing, and submission of high-quality dossiers in eCTD, NeeS, and paper formats.

Our Expertise

Our regulatory experts stay up to date with evolving agency expectations across major markets such as the USA (FDA), Europe (EMA), Canada (Health Canada), Japan (PMDA), Australia (TGA), Singapore (HSA), and other emerging regions. By combining regulatory precision with technical excellence, Techsol ensures every submission is accurate, compliant, and globally accepted.

Our Capabilities Include:

Dossier Preparation

Preparing a regulatory dossier involves compiling all required scientific, clinical, and administrative documentation to support a drug or biologic application for marketing authorization or clinical trial approval with a health authority (e.g., FDA, EMA, Health Canada).

Our team is highly experienced in assembling dossiers for a wide range of application types, including IND, NDA, ANDA, BLA, CTA, and MAA, tailored to the specifications of global agencies such as the FDA, EMA, Health Canada, MHRA, and others.

Techsol’s Regulatory Dossier preparation services include:

We specialize in preparing high-quality documents across all modules of the Common Technical Document (CTD/eCTD) format, including:

As part of our end-to-end eCTD Publishing Services, Techsol Life Sciences ensures all documents meet stringent PDF specifications required by global regulatory authorities. Proper formatting of PDFs is critical for submission acceptance, navigation, validation, and review by agencies like the FDA, EMA, Health Canada, and others.

Publishing Tools and Platforms

We are Skilled in using industry-standard publishing tools such as EXTEDO eCTD manager, Lorenz docuBridge. and follow strict quality control processes to deliver error-free, submission-ready eCTD sequences, helping you achieve faster approvals and regulatory compliance.

Key PDF Compliance Activities Include:

File Version and Format Standardization

All documents are converted to PDF 1.4 or 1.7 (as required) to ensure compatibility with agency review tools and validation software.

Optimized File Size and Resolution

Images, scans, and embedded content are optimized to maintain clarity while reducing file size, enhancing upload speed and system performance.

Document Navigation

Include bookmarks and a hyperlinked Table of Contents for documents longer than five pages. Use relative paths for hyperlinks.

Hyperlinks should open in a new window
Use “Inherit Zoom” for destination view

Fonts and Text Accessibility

All fonts are embedded, and text is searchable/selectable, allowing agency reviewers to easily annotate and extract information.

Security and Accessibility Settings

Documents are free from encryption, password protection, and editing restrictions, meeting regulatory expectations for open document review.

Fast Web View Enabled

PDFs are saved with Fast Web View enabled, allowing faster rendering during online review by agency assessors.

Consistent Headers, Footers, and Pagination

Each file adheres to submission unit requirements with consistent naming, pagination, and standardized headers/footers.

At Techsol Life Sciences, we utilize advanced publishing tools and follow global regulatory guidelines to ensure that every document submitted is technically compliant and review-ready. Our meticulous approach to PDF property management minimizes the risk of validation errors and enhances overall submission quality.

Techsol has deep regional expertise in North America (USA and Canada) and Europe and other countries. Techsol provides end-to-end support for eCTD publishing, NeeS, and paper-based submissions.