PHARMACEUTICAL REGULATORY AFFAIRS
CTD/eCTD Dossier Preparation & Review
Consistent, reviewable regulatory dossiers and electronic submission support.
SERVICE 02
Dossier development
We assist with dossier structuring and review in accordance with the Common Technical Document (CTD), with emphasis on technical accuracy, traceability and alignment between modules.
Regulatory and scientific review
Reviews can identify inconsistencies, missing documentation, outdated references and gaps between the proposed product information and supporting dossier evidence.
eCTD publishing and regulatory submission
NORD CONSULTING provides eCTD publishing and regulatory submission services for human medicinal products, supporting the preparation, validation and submission of electronic regulatory dossiers. Services include sequence preparation, technical validation and coordination of electronic submission activities with the relevant regulatory authority.
Lifecycle sequences
Where agreed, support covers sequences for initial applications, variations, renewals and other regulatory maintenance submissions, including management of technical validation questions.
Typical support activities
- CTD module organisation and dossier compilation
- Dossier readiness and consistency assessment
- eCTD publishing and sequence preparation
- Technical validation and submission package preparation
- Submission coordination with MHRA, EMA or relevant authorities
- Lifecycle sequence management and technical deficiency support
Services and deliverables are subject to a project-specific scope of work and the relevant regulatory framework.
DISCUSS A PROJECT
Need specialist regulatory affairs support?
Get in touch to discuss the regulatory scope and documentation requirements for your project.