Regulatory Publishing

SciRegs International Inc. delivers reliable, high‑quality regulatory publishing services designed to support critical submission milestones with precision and confidence. Our experienced publishing professionals manage the full eCTD lifecycle, helping companies meet global regulatory requirements without delay or rework.

SciRegs®

With SciRegs®, clients gain a dependable regulatory publishing partner focused on accuracy, compliance, and seamless execution—allowing regulatory teams to stay focused on strategy, not formatting.

Comprehensive eCTD Publishing

End‑to‑end eCTD creation and submission, from document intake through final agency delivery

Structuring submissions in strict accordance with ICH electronic format and lifecycle standards

Proven support for FDA‑mandated eCTD submissions under 21 CFR 314, 601, and 312

Blind Regulatory Publishing You Can Trust

Blind Regulatory Publishing (Content‑Blind eCTD Publishing) ensures complete separation between content ownership and technical execution.

SciRegs assembles, validates, and submits eCTDs without reviewing or interpreting scientific or regulatory content.

Publishing is performed strictly using final, approved source files and detailed publisher instructions.

Your Regulatory Affairs team retains full control and accountability for content—SciRegs serves as a neutral, trusted publishing partner.

Technical Excellence & Compliance

Rigorous pre‑submission validation to reduce rejection risk

Alignment with:
- FDA eCTD Technical Specifications
- ICH eCTD v3.2.2

Early identification and resolution of technical issues to ensure submission readiness

Secure Submission Delivery

FDA ESG Portal submissions, including confirmation tracking and submission support