Electronic Regulatory Dossiers - Techsol Life Sciences

Life Cycle Management

Electronic Regulatory Dossiers

Our regulatory operations team specializes in dossier planning, compilation, publishing, and version control to facilitate seamless submissions across global regulatory agencies including the FDA, EMA, MHRA, Health Canada, and others.

Management of Electronic Regulatory Dossiers (eCTD / NeeS Formats)

Techsol offers end-to-end support for the creation, submission, and lifecycle management of electronic regulatory dossiers in compliance with eCTD (Electronic Common Technical Document) and NeeS (Non-eCTD electronic Submission) standards. We ensure your product dossiers remain compliant, submission-ready, and aligned with Health Authority expectations throughout the lifecycle of the product.

Our Services Include:

Initial dossier setup in eCTD or NeeS format
Lifecycle maintenance, including updates for variations, supplements, renewals, and responses to authority queries
Gap analysis and conversion of legacy dossiers from paper or NeeS to eCTD format
Validation and quality checks using industry-standard publishing tools
Submission planning and tracking, ensuring timely delivery and acknowledgment by Health Authorities
Metadata management, folder structure alignment, and document granularity support for high-quality submissions
Archiving and version control of all submitted dossiers to maintain audit readiness and regulatory transparency

Expertise and Value Proposition

Global Submission Expertise: We manage region-specific requirements for eCTD/NeeS across the US, EU, Canada, APAC, and other major markets
Regulatory Publishing Excellence: Our team uses validated industry tools and follows strict quality control protocols to deliver error-free, HA-compliant submissions
Efficient Lifecycle Updates: Techsol supports dossier maintenance for a wide range of submission types, including post-approval changes, safety updates, and labeling variations
Digital Compliance and Readiness: We keep your regulatory dossiers current, organized, and aligned with Health Authority expectations—reducing risk and ensuring faster approvals